| 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 | 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. | KZM,KQX,HCC | Device, Muscle Monitoring,Goniometer, Ac-Powered,Device, Biofeedback | MES 9000 Musculoskeletal System | ||
| 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 | 09413000078510 | Android | 100321 | Neurofeedback Software Application for Android | Axon | EXSURGO LIMITED |
| 2 | 09413000078459 | Large | 100161 | EEG Biofeedback (Neurofeedback) Kit - Largeincludes Axon EEG headset - Large, Ta EEG Biofeedback (Neurofeedback) Kit - Largeincludes Axon EEG headset - Large, Tablet with Axon Neurofeedback Software Application | Axon | EXSURGO LIMITED |
| 3 | 09413000078442 | Medium | 100160 | Neurofeedback Kit - Mediumincludes Axon EEG headset - Medium, Tablet with Axon N Neurofeedback Kit - Mediumincludes Axon EEG headset - Medium, Tablet with Axon Neurofeedback Software Application | Axon | EXSURGO LIMITED |
| 4 | 09413000078435 | Small | 100140 | Neurofeedback Kit - Smallincludes Axon EEG headset - Small, Tablet with Axon Neu Neurofeedback Kit - Smallincludes Axon EEG headset - Small, Tablet with Axon Neurofeedback Software Application | Axon | EXSURGO LIMITED |
| 5 | 09413000078428 | Large | 100143 | EEG Headset - Large | Axon | EXSURGO LIMITED |
| 6 | 09413000078411 | Small | 100141 | EEG Headset - Small | Axon | EXSURGO LIMITED |
| 7 | 09413000077094 | Medium | 100142 | EEG Headset - Medium | Axon | EXSURGO LIMITED |
| 8 | 08809475370012 | MAW2017 | Make a Way ECG Monitor | MAKE A WAY CO.,LTD. | ||
| 9 | 08809475370005 | BBSMT01 | Make a Way PREGNANT WOMEN & FETAL HEALTH MONITOR | MAKE A WAY CO.,LTD. | ||
| 10 | 08719481550349 | 1.2 | The NeXus-10 MKII is designed for medical use, not restricted to a specific medi The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/acces professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MKII is not intended for use in diagnosis, nor in critical and/or life supporting applications.The NeXus 10 MKII is intended for use on humans.The NeXus 10 MKII is intended to be used with approved NeXus 10 MKII accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus-10 MKII and may require interpretation by user or application software. | NeXus-10 MKII | MIND MEDIA B.V. | |
| 11 | 08719481550332 | 1.0.204.6 | The NeXus software is intended to provide (near) real-time biofeedback and neuro The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes. | NeXus Software | MIND MEDIA B.V. | |
| 12 | 08719481550097 | 1.0 | NC-C-GT:The GSR sensor provides a measure of skin resistance or skin conductance NC-C-GT:The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes.The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment. | GSR-TMP Combination Sensor (NC-C-GT) | MIND MEDIA B.V. | |
| 13 | 08719481550080 | 1.0 | NB-TMP:The temperature sensor provides a signal that corresponds with (variation NB-TMP:The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment. | Temperature Sensor (NB-TMP) | MIND MEDIA B.V. | |
| 14 | 08719481550073 | 1.0 | NB-GSR:The GSR sensor provides a measure of skin resistance or skin conductance NB-GSR:The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment. | Galvanic Skin Response Sensor (NB-GSR) | MIND MEDIA B.V. | |
| 15 | 08719481550066 | 1.0 | NC-BVP-H (head module):The BVP sensor provides a photoplethysmography (PPG) sign NC-BVP-H (head module):The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment. | Blood Volume Pulse Sensor (NC-BVP-H) | MIND MEDIA B.V. | |
| 16 | 08719481550059 | 1.0 | NC-BVP-F (finger module):The BVP sensor provides a photoplethysmography (PPG) si NC-BVP-F (finger module):The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment. | Blood Volume Pulse Sensor (NC-BVP-F) | MIND MEDIA B.V. | |
| 17 | 08719481550042 | 1.0 | NB-BVP-H (head module):The BVP sensor provides a photoplethysmography (PPG) sign NB-BVP-H (head module):The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment. | Blood Volume Pulse Sensor (NB-BVP-H) | MIND MEDIA B.V. | |
| 18 | 08719481550035 | 1.0 | NB-BVP-F (finger module):The BVP sensor provides a photoplethysmography (PPG) si NB-BVP-F (finger module):The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment. | Blood Volume Pulse Sensor (NB-BVP-F) | MIND MEDIA B.V. | |
| 19 | 08719481550004 | 2.0 | The NeXus-Q32 is intended for acquisition of (electro)-physiological signals (e. The NeXus-Q32 is intended for acquisition of (electro)-physiological signals (e.g. EEG, surface EMG or ECG) from humans, regardless of any specific medical indication, by medical/research professionals. | NeXus-Q32 | MIND MEDIA B.V. | |
| 20 | 08592566001048 | TS-32NFB | TS-32NFB | 32 channel neurofeedback device | TruScan Neurofeedback 32ch | DEYMED DIAGNOSTIC S.R.O. |
| 21 | 08592566001024 | TS-24NFB | TS-24NFB | 24 channel neurofeedback device | TruScan Neurofeedback 24ch | DEYMED DIAGNOSTIC S.R.O. |
| 22 | 08056446900666 | B9700041000 | Isolation Transformer for EEG/EMG/EP systems | Isolation Transformer ‘GP’ 220-240 VAC 50/60 Hz | EB NEURO SPA | |
| 23 | 08056446900659 | B9700041001 | Isolation Transformer for EEG/EMG/EP systems | Isolation Transformer ‘GP’ 110-120 VAC 50/60 Hz | EB NEURO SPA | |
| 24 | 08056446900642 | B8640053000 | Software for EEG, EMG, EP and other applications based on acquiring, processing Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version. | Galileo NT Line Software | EB NEURO SPA | |
| 25 | 08056446900260 | B9700051000 | Interface for EMG/EP Amplifier | R-KEY (Dedicated Keyboard) | EB NEURO SPA | |
| 26 | 08056446900253 | B9700070100 | Interface for EMG/EP Amplifier | Power-LAN Connection Box USB | EB NEURO SPA | |
| 27 | 08056446900246 | B9700070000 | Interface for EMG/EP Amplifier | Power-LAN Connection Box | EB NEURO SPA | |
| 28 | 08056446900239 | B9700066000 | EMG/EP Amplifier | NeMus 1 | EB NEURO SPA | |
| 29 | 08056446900222 | B9800066000 | EMG/EP Amplifier with accessories | NeMus 1 | EB NEURO SPA | |
| 30 | 08056446900215 | B9800066800 | EMG/EP System | NeMus PC PERIPHERAL | EB NEURO SPA | |
| 31 | 08056446900208 | B9800066600 | EMG/EP System | NeMus SYSTEM | EB NEURO SPA | |
| 32 | 08055765540003 | APTIVA 4 | 905-000-004 | FREMSLIFE | FREMSLIFE SRL | |
| 33 | 08055765540003 | APTIVA 4 | 905-000-004 | FREMSLIFE | FREMSLIFE SRL | |
| 34 | 07640174660285 | ArmeoSenso | Armeo | HOCOMA AG | ||
| 35 | 07540191000623 | SA4520 | eVu Senz App iOS | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 36 | 07540191000616 | SA9005 | Vaginal Pressure Probe | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 37 | 07540191000609 | SA9003 | Pressure Sensor | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 38 | 07540191000562 | SA7904 | NEUROINFINITI 2 | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 39 | 07540191000555 | SA9000 | MyOnyx | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 40 | 07540191000548 | SA9013 | MyOnyx Mobile App | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 41 | 07540191000531 | SA2076 | Dual Sensitivity Meter | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 42 | 07540191000524 | SA2000M | GSR2 Unit Protected Pin | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 43 | 07540191000517 | SA2050M | Remote Electrodes, GSR2 PP | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 44 | 07540191000500 | SA2090M | Reverse Temp Sensor, GSR2PP | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 45 | 07540191000487 | SA4502 | eVu Senz App | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 46 | 07540191000470 | SA4500 | Triple Physiology Sensor (TPS) | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 47 | 07540191000463 | T2001M | GSR2 B.F. System | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 48 | 07540191000456 | T2120M | GSR/TEMP 2X B.F. System | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 49 | 07540191000449 | SA7900 | Biograph Infiniti Software | TECHNOLOGIE DE PENSÉE LTÉE | ||
| 50 | 07540191000418 | SA9572 | Vaginal Stim Sensor | TECHNOLOGIE DE PENSÉE LTÉE |