| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | D79244500 | J5 | 4450 | The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologica The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologically relaxed state of the muscles of mastication. | NUW | Stimulator, Muscle, Powered, Dental | J5 Myo-Monitor | |
| 2 | D79209940 | K7/CMS | Multiple sensors in an extremely light weight (four ounce) spectacle-like array, Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training. | NFS,IKN,KZM | Device, Jaw Tracking, For Monitoring Jaw Positions,Electromyograph, Diagnostic,D Device, Jaw Tracking, For Monitoring Jaw Positions,Electromyograph, Diagnostic,Device, Muscle Monitoring | K7 Evaluation System-CMS | ||
| 3 | D79209930 | K7/EMG | Utilizing high quality bipolar surface electrodes, surface EMG data can be taken Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography data either at rest or in function. All eight channels may be displayed simultaneously, for a period of 15 seconds (one visual screen width). The K7/EMG signal processing circuitry provides unsurpassed protection against system noise or motion artifact. The patient education mode permits quick and easy patient education as to status of masticatory muscles. | KZM,NFS,IKN | Device, Muscle Monitoring,Device, Jaw Tracking, For Monitoring Jaw Positions,Ele Device, Muscle Monitoring,Device, Jaw Tracking, For Monitoring Jaw Positions,Electromyograph, Diagnostic | 1 | K7 Evaluation System-EMG | |
| 4 | D79209750 | K7/ESG | TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sens TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function. | KZM,IKN,NFS,NFQ | Device, Muscle Monitoring,Electromyograph, Diagnostic,Device, Jaw Tracking, For Device, Muscle Monitoring,Electromyograph, Diagnostic,Device, Jaw Tracking, For Monitoring Jaw Positions,Device, Dental Sonography, For Monitoring Jaw Sounds | 1 | K7 Evaluation System-ESG | |
| 5 | D7921013 | 101 | High quality disposable (single use) electrodes for surface electromyography (EMG). | KZM,NUW | Device, Muscle Monitoring,Stimulator, Muscle, Powered, Dental | 2 | Monotrode 101 | |
| 6 | D79240702 | 4070 | Non-jelled TENS Electrodes for use with Myomonitor.Designed for patients with s Non-jelled TENS Electrodes for use with Myomonitor.Designed for patients with sideburns or a beard. | NUW | Stimulator, Muscle, Powered, Dental | 2 | Myotrode One without Gel | |
| 7 | D792N150MES0 | Static EMG Scanner | Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpasse Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "noise", provides an SEMG platform you can use with confidence. With Noromed SEMG you know you are getting true, reliable and repeatable results.In evaluating the technological sophistication, superiority and reliability of SEMG systems, the most important factors are sensitivity (usually expressed in microvolts), the monitoring range (again usually expressed in microvolts), and how the instrument eliminates ambient electrical noise. | HCC,KZM,IKN | Device, Biofeedback,Device, Muscle Monitoring,Electromyograph, Diagnostic | MES 9000 Static Electromyography Scanner | ||
| 8 | D79261451 | 6145 | Duotrodes are silver-silver chloride, bi-polar electrodes for surface EMG applications. | IKN | Electromyograph, Diagnostic | Myotronics 6145 Duotrodes | ||
| 9 | D79240602 | 4060 | Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with s Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard. | NUW | Stimulator, Muscle, Powered, Dental | 2 | Myotrode One With Gel | |
| 10 | D792N9600A0 | Muscle Tester | Noromed computerized manual muscle testing offers manual muscle testing at its b Noromed computerized manual muscle testing offers manual muscle testing at its best by bringing science to what once was an art.The muscle testing hardware includes an ergonomic force gauge and five attachments to choose from which provide easy, comfortable testing of all muscle groups - large and small. Now you can perform real time strength testing - quickly and easily - and all fully documented by the computer interface.The flexibility of the system allows you to use pre-programmed established protocols or create your own. Designed to meet your needs, the software calculates the statistics appropriate to each test as well as generating a wide variety of documentation to fit your specific needs. This documentation includes:Supportive documentation reports which contain the graphic reports and profiles of the actual test data. Reports included are:•A composite report of individual test results by protocol and muscles tested as well as calculated deficits. •A test comparison report which collects and displays the patient's historical results. •A Myotest data report which presents both statistical data and graphical data of the individual test broken down by trial. | HCC,KZM | Device, Biofeedback,Device, Muscle Monitoring | 2 | MES 9000 Muscle Tester | |
| 11 | D792N9200A0 | MES 9000 EMG | The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 chan The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 channels of SEMG simultaneously. The MES 9000 offers you the flexibility to monitor and record the data in its raw state or as integrated data.The powerful and user-friendly software simplifies the recording of multiple muscle groups of antagonist and synergist muscles to facilitate assessment and case documentation. In addition, the system includes pre-programmed protocols and analysis for assessment, muscle education and relaxation training. The clinician may also program custom protocols - quickly and simply. | KZM,HCC,IKN | Device, Muscle Monitoring,Device, Biofeedback,Electromyograph, Diagnostic | 2 | MES 9000 Dynamic EMG | |
| 12 | D792N36010 | NT360 | By using sophisticated sensors within the inclinometers, the Dynamic ROM system By using sophisticated sensors within the inclinometers, the Dynamic ROM system records the patient's entire ROM through the plane of movement and displays it in a graphical representation on the computer screen. Unlike other systems which simply give you a static endpoint measurement of ROM, Dynamic ROM captures the entire movement. The figure to your left shows a typical Dynamic ROM recording of the dynamic motion of the spine during three repetitions of lumbar flexion and extension. The numbers correspond with the figure to the left showing the patient's motions.The inclinometers are attached to straps placed over T12 and S1. The recording of the sensor at S1 is subtracted from the recording at T12 to produce the DIFFerential recording graph which represents the true motion of the patient's lumbar during lumbar flexion and extension motion. The flattened DIFF tracing line on each repetition during end-point indicates that both sensors are moving at the same rate of speed, and that the lumbar lordosis stopped unfolding before the end-point of trunk flexion had been reached. With this information the clinician can observe and assess the quality and the pattern of the patient's motion as well as the quantity of the ROM. Dynamic Range of Motion from Noromed elevates range of motion testing from a simple measurement tool to a true diagnostic tool. | KQX,HCC | Goniometer, Ac-Powered,Device, Biofeedback | 1 | Noromed NT-360 Inclinometer | |
| 13 | D792N12011 | N120 | NOROTRODES are silver-silver chloride electrodes for surface EMG applications. C NOROTRODES are silver-silver chloride electrodes for surface EMG applications. Contact surfaces pre-jelled with hypoallergenic jel that is water soluble for quick cleanup. Mounted on hypoallergenic adhesive. Silver snap connectors. | IKN | Electromyograph, Diagnostic | Norotrode 20 | ||
| 14 | D79245000 | BNS-40 | 4500 | The BNS-40 is a miniaturized version of the Myomonitor designed to allow the pat The BNS-40 is a miniaturized version of the Myomonitor designed to allow the patient to safely apply electrical stimulation while at home to relax tense muscles. | NUW | Stimulator, Muscle, Powered, Dental | 2 | BNS-40 Home Treatment Unit |
| 15 | D79243001 | 4300 | 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total).A re 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total).A revolutionary electrode designed especially for use with the Myomonitor and BNS-40 unit. | NUW | Stimulator, Muscle, Powered, Dental | Myotrode SG Solid Gel TENS Electrodes | ||
| 16 | D79209950 | EMG | 0995 | Utilizing high quality bipolar surface electrodes, surface EMG data can be taken Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography data either at rest or in function. All eight channels may be displayed simultaneously, for a period of 15 seconds (one visual screen width). The K7/EMG signal processing circuitry provides unsurpassed protection against system noise or motion artifact. The patient education mode permits quick and easy patient education as to status of masticatory muscles. | KZM | Device, Muscle Monitoring | 2 | K7 EMG Electromyograph |
| 17 | D79209960 | K7 CMS Sensor Array | 0996 | Multiple sensors in an extremely light weight (four ounce) spectacle-like array, Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training. | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | K7 CMS Sensor Array |
| 18 | D79209830 | ESG-2 | 0983 | TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sens TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function. | NFQ | Device, Dental Sonography, For Monitoring Jaw Sounds | 1 | K7 ESG-2 Electrosonograph |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | D792N9600A0 | Muscle Tester | Noromed computerized manual muscle testing offers manual muscle testing at its b Noromed computerized manual muscle testing offers manual muscle testing at its best by bringing science to what once was an art.The muscle testing hardware includes an ergonomic force gauge and five attachments to choose from which provide easy, comfortable testing of all muscle groups - large and small. Now you can perform real time strength testing - quickly and easily - and all fully documented by the computer interface.The flexibility of the system allows you to use pre-programmed established protocols or create your own. Designed to meet your needs, the software calculates the statistics appropriate to each test as well as generating a wide variety of documentation to fit your specific needs. This documentation includes:Supportive documentation reports which contain the graphic reports and profiles of the actual test data. Reports included are:•A composite report of individual test results by protocol and muscles tested as well as calculated deficits. •A test comparison report which collects and displays the patient's historical results. •A Myotest data report which presents both statistical data and graphical data of the individual test broken down by trial. | MES 9000 Muscle Tester | MYOTRONICS NOROMED, INC | |
| 2 | D792N9600A0 | Muscle Tester | Noromed computerized manual muscle testing offers manual muscle testing at its b Noromed computerized manual muscle testing offers manual muscle testing at its best by bringing science to what once was an art.The muscle testing hardware includes an ergonomic force gauge and five attachments to choose from which provide easy, comfortable testing of all muscle groups - large and small. Now you can perform real time strength testing - quickly and easily - and all fully documented by the computer interface.The flexibility of the system allows you to use pre-programmed established protocols or create your own. Designed to meet your needs, the software calculates the statistics appropriate to each test as well as generating a wide variety of documentation to fit your specific needs. This documentation includes:Supportive documentation reports which contain the graphic reports and profiles of the actual test data. Reports included are:•A composite report of individual test results by protocol and muscles tested as well as calculated deficits. •A test comparison report which collects and displays the patient's historical results. •A Myotest data report which presents both statistical data and graphical data of the individual test broken down by trial. | MES 9000 Muscle Tester | MYOTRONICS NOROMED, INC | |
| 3 | D792N9200A0 | MES 9000 EMG | The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 chan The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 channels of SEMG simultaneously. The MES 9000 offers you the flexibility to monitor and record the data in its raw state or as integrated data.The powerful and user-friendly software simplifies the recording of multiple muscle groups of antagonist and synergist muscles to facilitate assessment and case documentation. In addition, the system includes pre-programmed protocols and analysis for assessment, muscle education and relaxation training. The clinician may also program custom protocols - quickly and simply. | MES 9000 Dynamic EMG | MYOTRONICS NOROMED, INC | |
| 4 | D792N9200A0 | MES 9000 EMG | The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 chan The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 channels of SEMG simultaneously. The MES 9000 offers you the flexibility to monitor and record the data in its raw state or as integrated data.The powerful and user-friendly software simplifies the recording of multiple muscle groups of antagonist and synergist muscles to facilitate assessment and case documentation. In addition, the system includes pre-programmed protocols and analysis for assessment, muscle education and relaxation training. The clinician may also program custom protocols - quickly and simply. | MES 9000 Dynamic EMG | MYOTRONICS NOROMED, INC | |
| 5 | D792N9000M0 | N9000M | Now you can have all of these capabilities in one compact system. Surface EMG, r Now you can have all of these capabilities in one compact system. Surface EMG, rangeof motion and muscle testing – may be purchased separately or in any combination. The modulardesign of the MES 9000 allows you to purchase any combination of modules and expand as yourpractice grows. The MES 9000 --- the modular system that enables you to do a complete, integratedevaluation with objective documentation that supports your diagnosis. | MES 9000 Musculoskeletal System | MYOTRONICS NOROMED, INC | |
| 6 | D792N9000M0 | N9000M | Now you can have all of these capabilities in one compact system. Surface EMG, r Now you can have all of these capabilities in one compact system. Surface EMG, rangeof motion and muscle testing – may be purchased separately or in any combination. The modulardesign of the MES 9000 allows you to purchase any combination of modules and expand as yourpractice grows. The MES 9000 --- the modular system that enables you to do a complete, integratedevaluation with objective documentation that supports your diagnosis. | MES 9000 Musculoskeletal System | MYOTRONICS NOROMED, INC | |
| 7 | D792N9000M0 | N9000M | Now you can have all of these capabilities in one compact system. Surface EMG, r Now you can have all of these capabilities in one compact system. Surface EMG, rangeof motion and muscle testing – may be purchased separately or in any combination. The modulardesign of the MES 9000 allows you to purchase any combination of modules and expand as yourpractice grows. The MES 9000 --- the modular system that enables you to do a complete, integratedevaluation with objective documentation that supports your diagnosis. | MES 9000 Musculoskeletal System | MYOTRONICS NOROMED, INC | |
| 8 | D792N36010 | NT360 | By using sophisticated sensors within the inclinometers, the Dynamic ROM system By using sophisticated sensors within the inclinometers, the Dynamic ROM system records the patient's entire ROM through the plane of movement and displays it in a graphical representation on the computer screen. Unlike other systems which simply give you a static endpoint measurement of ROM, Dynamic ROM captures the entire movement. The figure to your left shows a typical Dynamic ROM recording of the dynamic motion of the spine during three repetitions of lumbar flexion and extension. The numbers correspond with the figure to the left showing the patient's motions.The inclinometers are attached to straps placed over T12 and S1. The recording of the sensor at S1 is subtracted from the recording at T12 to produce the DIFFerential recording graph which represents the true motion of the patient's lumbar during lumbar flexion and extension motion. The flattened DIFF tracing line on each repetition during end-point indicates that both sensors are moving at the same rate of speed, and that the lumbar lordosis stopped unfolding before the end-point of trunk flexion had been reached. With this information the clinician can observe and assess the quality and the pattern of the patient's motion as well as the quantity of the ROM. Dynamic Range of Motion from Noromed elevates range of motion testing from a simple measurement tool to a true diagnostic tool. | Noromed NT-360 Inclinometer | MYOTRONICS NOROMED, INC | |
| 9 | D792N36010 | NT360 | By using sophisticated sensors within the inclinometers, the Dynamic ROM system By using sophisticated sensors within the inclinometers, the Dynamic ROM system records the patient's entire ROM through the plane of movement and displays it in a graphical representation on the computer screen. Unlike other systems which simply give you a static endpoint measurement of ROM, Dynamic ROM captures the entire movement. The figure to your left shows a typical Dynamic ROM recording of the dynamic motion of the spine during three repetitions of lumbar flexion and extension. The numbers correspond with the figure to the left showing the patient's motions.The inclinometers are attached to straps placed over T12 and S1. The recording of the sensor at S1 is subtracted from the recording at T12 to produce the DIFFerential recording graph which represents the true motion of the patient's lumbar during lumbar flexion and extension motion. The flattened DIFF tracing line on each repetition during end-point indicates that both sensors are moving at the same rate of speed, and that the lumbar lordosis stopped unfolding before the end-point of trunk flexion had been reached. With this information the clinician can observe and assess the quality and the pattern of the patient's motion as well as the quantity of the ROM. Dynamic Range of Motion from Noromed elevates range of motion testing from a simple measurement tool to a true diagnostic tool. | Noromed NT-360 Inclinometer | MYOTRONICS NOROMED, INC | |
| 10 | D792N150MES0 | Static EMG Scanner | Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpasse Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "noise", provides an SEMG platform you can use with confidence. With Noromed SEMG you know you are getting true, reliable and repeatable results.In evaluating the technological sophistication, superiority and reliability of SEMG systems, the most important factors are sensitivity (usually expressed in microvolts), the monitoring range (again usually expressed in microvolts), and how the instrument eliminates ambient electrical noise. | MES 9000 Static Electromyography Scanner | MYOTRONICS NOROMED, INC | |
| 11 | D792N150MES0 | Static EMG Scanner | Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpasse Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "noise", provides an SEMG platform you can use with confidence. With Noromed SEMG you know you are getting true, reliable and repeatable results.In evaluating the technological sophistication, superiority and reliability of SEMG systems, the most important factors are sensitivity (usually expressed in microvolts), the monitoring range (again usually expressed in microvolts), and how the instrument eliminates ambient electrical noise. | MES 9000 Static Electromyography Scanner | MYOTRONICS NOROMED, INC | |
| 12 | D7921013 | 101 | High quality disposable (single use) electrodes for surface electromyography (EMG). | Monotrode 101 | MYOTRONICS NOROMED, INC | |
| 13 | D79209950 | EMG | 0995 | Utilizing high quality bipolar surface electrodes, surface EMG data can be taken Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography data either at rest or in function. All eight channels may be displayed simultaneously, for a period of 15 seconds (one visual screen width). The K7/EMG signal processing circuitry provides unsurpassed protection against system noise or motion artifact. The patient education mode permits quick and easy patient education as to status of masticatory muscles. | K7 EMG Electromyograph | MYOTRONICS NOROMED, INC |
| 14 | D79209940 | K7/CMS | Multiple sensors in an extremely light weight (four ounce) spectacle-like array, Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training. | K7 Evaluation System-CMS | MYOTRONICS NOROMED, INC | |
| 15 | D79209930 | K7/EMG | Utilizing high quality bipolar surface electrodes, surface EMG data can be taken Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography data either at rest or in function. All eight channels may be displayed simultaneously, for a period of 15 seconds (one visual screen width). The K7/EMG signal processing circuitry provides unsurpassed protection against system noise or motion artifact. The patient education mode permits quick and easy patient education as to status of masticatory muscles. | K7 Evaluation System-EMG | MYOTRONICS NOROMED, INC | |
| 16 | D79209750 | K7/ESG | TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sens TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function. | K7 Evaluation System-ESG | MYOTRONICS NOROMED, INC | |
| 17 | 00190446163985 | 5923-3 | VITALSTIM PLUS ELECTROTHERAPY SYSTEM | CHATTANOOGA | DJO, LLC | |
| 18 | 00092237623817 | DQ2000 | TheraTouch UX2 Stand Alone Ultrasound | TheraTouch UX2 | COMPASS HEALTH BRANDS CORP. | |
| 19 | 00082161071051 | 07105 | Pressure monitoring insole | Intellinetix | BROWNMED, INC. | |
| 20 | B7580356300000000000001 | 30Min-DAP | 0356-30 | Single use disposable application pad adhesive for use with dorsaVi Version 5 MD Single use disposable application pad adhesive for use with dorsaVi Version 5 MDM Sensors for Movement Suite Kits. | 30 Minute Disposable Application Pad | DORSAVI LTD |
| 21 | B7580000VMV50000000000 | 0000VMV50000000000 | VMV50 | Movement Suite is a wireless medical device that measures, records, and reports Movement Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lowerback / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes. | Movement Suite / V5 Sensor Kit | DORSAVI LTD |
| 22 | B7580000VMV50000000000 | 0000VMV50000000000 | VMV50 | Movement Suite is a wireless medical device that measures, records, and reports Movement Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lowerback / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes. | Movement Suite / V5 Sensor Kit | DORSAVI LTD |
| 23 | B7580000RDA482000000000 | V6 Sensor Adhesive | RS-A482 | Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors. | dorsaVi | DORSAVI LTD |
| 24 | B7580000PS100000000000 | 0000PS100000000000 | PS100 | Professional Suite is a wireless medical device that measures, records, and repo Professional Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lowerback / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes. | Professional Suite | DORSAVI LTD |
| 25 | B7580000PS100000000000 | 0000PS100000000000 | PS100 | Professional Suite is a wireless medical device that measures, records, and repo Professional Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lowerback / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes. | Professional Suite | DORSAVI LTD |
| 26 | B58804E0 | A404 | EEG Amplifier | Phoenix EEG Amplifier | SOUTHEAST SIGNAL, INC | |
| 27 | B58802L0 | A200 | EEG Amplifier | Ochs Labs EEG Amplifier | SOUTHEAST SIGNAL, INC | |
| 28 | B58802E0 | A202 | EEG Amplifier | Phoenix EEG Amplifier | SOUTHEAST SIGNAL, INC | |
| 29 | B258EEGER4 | 4 | Neurofeedback Software | EEGer4 | EEG SOFTWARE LLC | |
| 30 | B184A100020 | A10002 | A10002 | NTrainer System | NTrainer | INNARA HEALTH, INC. |
| 31 | B184A000020 | A00002 | A00002 | NTrainer System | NTrainer | INNARA HEALTH, INC. |
| 32 | B179TMJ | 1.0 | BTSEMB1BM | BTS TMJOINT is a wireless surface electromyograph to measure thedifferential in BTS TMJOINT is a wireless surface electromyograph to measure thedifferential influence of the occlusal function through indices validatedand published in scientific literature | TMJOINT | BTS SPA |
| 33 | B179THN2 | 2.0 | BTSEMB1BM | Indication for use: To record electrical activity of 2 muscles of the stomatogna Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter Toclinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity ofmuscles of the stomatognathic system To measure relative (intra-patient) levels of activity of 2 muscles during a functional act | TEETHAN | BTS SPA |
| 34 | B179OMN | 1.0 | BTSEMB1BM | BTS OMNIsEMG is an instrument for the electromyographic surface analysis. | OMNIsEMG | BTS SPA |
| 35 | B179GSN2 | 2 | BTSGSN2 | BTS G-SENSOR 2 is a wireless system consisting of an inertial sensor composed by BTS G-SENSOR 2 is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tri-axial gyroscope, that worn by the patient allows a functional gait analysis. | G-SENSOR | BTS SPA |
| 36 | B179FR1 | 1000 | BTSEMB1BM | BTS FREEEMG 1000 is a wireless surface electromyograph for the acquisition and t BTS FREEEMG 1000 is a wireless surface electromyograph for the acquisition and transmission of EMG signals and for the assessment of angles, angular velocities, angular accelerations and foot-floor contact areas.It allows the functional evaluation and a real-time visualization of the acquired signals for biofeedback and monitoring applications. | FREEEMG | BTS SPA |
| 37 | B179FE3 | 300 | BTSFE3 | BTS FREEEMG 300 is a wireless surface electromyograph, which makes the selection BTS FREEEMG 300 is a wireless surface electromyograph, which makes the selection of muscles, the setting ofduration and frequency of acquisition, amplification gain and the correctpositioning of electrodes, simple and rapid. | FREEEMG | BTS SPA |
| 38 | B179BAIO1 | 1 | BAIOBIT is a wireless system consisting of an inertial sensor composed by a tri- BAIOBIT is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tri-axial gyroscope, that worn by the patient allows a functional movement analysis. | baiobit | BTS SPA | |
| 39 | 55060808320076 | SW-1.3-MSAPP | SW-1.3-MSAPP | MotionSense Application Version 1.3 | MotionSense Application Version 1.3 | ENMOVI LTD |
| 40 | 55060808320007 | MotionSense 2.0 | 007-00036-US | MotionSense Digital Goniometer | ENMOVI LTD | |
| 41 | 15694311111665 | NOX-NOXTURNAL_US_APP | Noxturnal US APP | NOX MEDICAL EHF. | ||
| 42 | 15694311111627 | APSGH1PAC1US | 561112 | Nox A1® EEG Head Cable | NOX MEDICAL EHF. | |
| 43 | 15694311111610 | ECUP5AU1PAC1US | 554412 | Nox A1® EEG 5 Lead Gold Electrode Cable | NOX MEDICAL EHF. | |
| 44 | 15694311111597 | NOX-C1SKIT1_US | 544024 | Nox C1s Kit | NOX MEDICAL EHF. | |
| 45 | 15694311111580 | NOX-A1S_USF | 513113 | Nox A1s System | NOX MEDICAL EHF. | |
| 46 | 15694311111566 | NOX-APSG1SUS | 561121 | Nox A1s Recorder | NOX MEDICAL EHF. | |
| 47 | 15694311111504 | NOX-C1KIT1_US | 544021 | Nox C1 Kit | NOX MEDICAL EHF. | |
| 48 | 15694311111498 | NOX-SCOM1US | Nox C1 Access Point | NOX MEDICAL EHF. | ||
| 49 | 15694311111375 | NOX-A1PSG_USF | 513510 | Nox A1 System | NOX MEDICAL EHF. | |
| 50 | 15694311111368 | NOX-NOXTPSG_CD | 539012 | Noxturnal PSG CD | NOX MEDICAL EHF. |