No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 08051122041220 | P005_AS034_17 | Surgical instrument to be used with Superelastic Transosseous Needle (STN). | LXH | Orthopedic Manual Surgical Instrument | 1 | Taylor Stitcher Cannula | |
2 | 08051122041176 | P005_AS034_06 | Surgical instrument to be used with Superelastic Transosseous Needle (STN). | LXH | Orthopedic Manual Surgical Instrument | 1 | Taylor Stitcher Screw ring main body | |
3 | 08051122041121 | P005_AS034_01 | Surgical instrument to be used with Superelastic Transosseous Needle (STN). | LXH | Orthopedic Manual Surgical Instrument | 1 | Taylor Stitcher body | |
4 | 08051122041138 | P005_AS034_13 | Surgical instrument to be used with Superelastic Transosseous Needle (STN). | LXH | Orthopedic Manual Surgical Instrument | 1 | Elite Spk inserter | |
5 | 08051122041046 | SHWM01L6 | The Showmotion LOWER 6 kit includes 6 WISE sensors, a GATEWAY receiver, elastic The Showmotion LOWER 6 kit includes 6 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the lower district. | ISD | Exerciser, Measuring | 2 | LOWER LIMB KIT – 6 WISE | |
6 | 08051122041015 | GTWY01 | The GATEWAY is a 2.4 GHz wireless receiver that communicates with the WISE inert The GATEWAY is a 2.4 GHz wireless receiver that communicates with the WISE inertial sensor. | ISD | Exerciser, Measuring | 2 | Gateway | |
7 | 08051122040971 | SPM01K4 | SPM01K4 | For the wireless mode version of the subject device, combined with an applicatio For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a home environment, the content of the SPM01K4 convenience kit is: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM@Home mobile application (SPM01A2). | IPF,KQX | Stimulator, Muscle, Powered,Goniometer, Ac-Powered | 1 | Wireless app home mode - Kit |
8 | 08051122040964 | SPM01K3 | SPM01K3 | For the wireless mode version of the subject device, to be used in combination w For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SPM01K3 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM mobile application (SPM01A1). | IPF,KQX | Stimulator, Muscle, Powered,Goniometer, Ac-Powered | 1 | Wireless app mode - Kit |
9 | 08051122040957 | SPM01K2 | SPM01K2 | For the wireless mode version of the subject device, to be used in combination w For the wireless mode version of the subject device, to be used in combination with a dedicated control software running on a pc/laptop, the content of the SPM01K2 convenience kit is: 1 electrostimulator SPM01M2 configuration; electrodes, and protective skin. | IPF,KQX | Stimulator, Muscle, Powered,Goniometer, Ac-Powered | 1 | Wireless mode - Kit |
10 | 08051122040926 | SPM01A1 | SPM01A1 | Optionally, the electrostimulator (SPM01M1) can require the combined use with th Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols. | IPF,KQX | Stimulator, Muscle, Powered,Goniometer, Ac-Powered | 1 | MySPM App |
11 | 08051122040018 | A000115 | A000115 | The implantable device Elite SPK is intended for the attachment of soft tissue t The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. The implant device is packaged with previously cleared sutures, in their final sterilized form | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | Elite SPK Kit |
12 | 08051122041183 | P005_AS034_08 | Surgical instrument to be used with Superelastic Transosseous Needle (STN). | LXH | Orthopedic Manual Surgical Instrument | 1 | Taylor Stitcher Screws | |
13 | 08051122040988 | GTTN00M1 | GT TUNNELER is a sterile, single-use device used in standard shoulder arthroscop GT TUNNELER is a sterile, single-use device used in standard shoulder arthroscopy procedures. | LXH | Orthopedic Manual Surgical Instrument | 1 | GT TUNNELER | |
14 | 08051122040933 | SPM01A2 | SPM01A2 | Optionally, the electrostimulator (SPM01M1) can require the combined use with th Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols. | IPF,KQX | Stimulator, Muscle, Powered,Goniometer, Ac-Powered | 1 | MySPM@Home App |
15 | 08051122040698 | P005_AS034 | Complete set of surgical instrument to be used with Superelastic Transosseous Ne Complete set of surgical instrument to be used with Superelastic Transosseous Needle (STN). | LXH | Orthopedic Manual Surgical Instrument | 1 | TAYLOR STITCHER | |
16 | 08051122041213 | P005_AS034_16 | Surgical instrument to be used with Superelastic Transosseous Needle (STN). | LXH | Orthopedic Manual Surgical Instrument | 1 | Taylor Stitcher Spanner 7mm | |
17 | 08051122041206 | P005_AS034_12 | Surgical instrument to be used with Superelastic Transosseous Needle (STN). | LXH | Orthopedic Manual Surgical Instrument | 1 | Taylor Stitcher Hammer | |
18 | 08051122041077 | SHWM01S2 | The Showmotion SPINE 2 kit includes 2 WISE sensors, a GATEWAY receiver, elastic The Showmotion SPINE 2 kit includes 2 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the spine. | ISD | Exerciser, Measuring | 2 | SPINE KIT – 2 WISE | |
19 | 08051122041008 | WISE01 | The WISE is a magnetic and inertial unit including 3D accelerometers, gyroscopes The WISE is a magnetic and inertial unit including 3D accelerometers, gyroscopes and magnetometers. | ISD | Exerciser, Measuring | 2 | WISE (wireless inertial sensor equipment) | |
20 | 08051122041060 | SHWM01T12 | The Showmotion TOTAL 12 kit includes 12 WISE sensors, a GATEWAY receiver, elasti The Showmotion TOTAL 12 kit includes 12 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the total body. | ISD | Exerciser, Measuring | 2 | TOTAL BODY KIT – 12 WISE | |
21 | 08051122041022 | SHWM01U5 | The Showmotion UPPER 5 kit includes 5 WISE sensors, a GATEWAY receiver, elastic The Showmotion UPPER 5 kit includes 5 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the upper district. | ISD | Exerciser, Measuring | 2 | UPPER LIMB KIT – 5 WISE | |
22 | 08051122040919 | SPM01M2 | SPM01M2 | The configuration is composed of an electrostimulator and other components, usef The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or controlling it. The SPM01M2 configuration supports IEEE 802.15.4 radio interface. In this case it provides for the exchange of data between the stimulator and a receiver connected to the PC, which then collects the data sent by the device and synchronizes the transmission. The dedicated control software is supplied via an usb receiver. | IPF,KQX | Stimulator, Muscle, Powered,Goniometer, Ac-Powered | 1 | Shoulder Pacemaker device (wireless PC) |
23 | 08051122040902 | SPM01M1 | SPM01M1 | The configuration is composed of an electrostimulator and other components, usef The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or controlling it.The SPM01M1 configuration supports Bluetooth Low Energy communication. In this case it can connect directly to a smartphone/tablet on which a dedicated app is installed. The dedicated control software is supplied via an usb receiver and must be used by a properly trained healthcare professional. | IPF,KQX | Stimulator, Muscle, Powered,Goniometer, Ac-Powered | 1 | Shoulder Pacemaker device |
24 | 08051122041152 | P005_AS034_04 | Surgical instrument to be used with Superelastic Transosseous Needle (STN). | LXH | Orthopedic Manual Surgical Instrument | 1 | Taylor Stitcher Screwdriver | |
25 | 08051122041145 | P005_AS034_03 | Surgical instrument to be used with Superelastic Transosseous Needle (STN). | LXH | Orthopedic Manual Surgical Instrument | 1 | Taylor Stitcher Punch | |
26 | 08051122041190 | P005_AS034_09 | Surgical instrument to be used with Superelastic Transosseous Needle (STN). | LXH | Orthopedic Manual Surgical Instrument | 1 | Taylor Stitcher Sterilization basket | |
27 | 08051122041169 | P005_AS034_05 | Surgical instrument to be used with Superelastic Transosseous Needle (STN). | LXH | Orthopedic Manual Surgical Instrument | 1 | Taylor Stitcher Targeting system | |
28 | 08051122041091 | SHWM01SW1 | Showmotion software can be used to control motion sensors hardware in order to t Showmotion software can be used to control motion sensors hardware in order to track kinematics of upper/lower body by means of specific biomechanical protocols. Showmotion software can also be used as a stand-alone system when opening a subject's database, playing back previously recorded analyses, and when generating specific reports or comparison analyses. In this configuration there is no need to connect with the hardware sensors. | ISD | Exerciser, Measuring | 2 | Software web Showmotion | |
29 | 08051122041084 | SHWM01S3 | The Showmotion SPINE 3 kit includes 3 WISE sensors, a GATEWAY receiver, elastic The Showmotion SPINE 3 kit includes 3 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the spine and the head. | ISD | Exerciser, Measuring | 2 | SPINE KIT – 3 WISE | |
30 | 08051122041039 | SHWM01U7 | The Showmotion UPPER 7 kit includes 7 WISE sensors, a GATEWAY receiver, elastic The Showmotion UPPER 7 kit includes 7 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the upper district. | ISD | Exerciser, Measuring | 2 | UPPER LIMB KIT – 7 WISE | |
31 | 08051122040995 | GTTN00M1-KF | GT TUNNELER device and non-adsorbable sutures. | LXH | Orthopedic Manual Surgical Instrument | 1 | GT TUNNELER KIT | |
32 | 08051122040940 | SPM01K1 | SPM01K1 | For the stand-alone mode version of the subject device, the SPM01K1 convenience For the stand-alone mode version of the subject device, the SPM01K1 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes, and protective skin. | IPF,KQX | Stimulator, Muscle, Powered,Goniometer, Ac-Powered | 1 | Stand-alone mode Kit |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B654LS0 | LEGSys | LEGSys™ is a wireless wearable system based on 9 degree-of-freedom inertial meas LEGSys™ is a wireless wearable system based on 9 degree-of-freedom inertial measurement sensors. LEGSys™ is intended for measuring spatiotemporal parameters of gait based on the joint angles of the lower limbs during human walking over ground or on a treadmill. Additionally for patients aged 70 and up, LEGSys™ is intended to assess a patient’s risk of falling based on measured spatiotemporal parameters of gait and published, publicly available, scientific data regarding fall risk. | LEGSys | BIOSENSICS LLC | |
2 | B628OPALV2C0 | V2C | OPALV2C | APDM's Opal V2C is a small worn monitor designed for documenting physical moveme APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable. | Opal V2C | APDM, INC. |
3 | B628DSV2C0 | V2C | DSV2C | APDM’s Docking Station is an accessory that transfers the raw sensor data logged APDM’s Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Docking Station recharges the battery of an Opal V2C. | Docking Station V2C | APDM, INC. |
4 | B628APV2C0 | V2C | APV2C | APDM’s Access Point is an accessory that enables wireless streaming to a compute APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C. | Access Point V2C | APDM, INC. |
5 | B493SW0043 | SW-0043 | Web application | Kintinuum™ | MC10, INC. | |
6 | B493SW0042 | SW-0042 | Patient application for Android | Kintinuum™ | MC10, INC. | |
7 | B493MC0016 | MC-0016 | Instructions for use | Kintinuum™ | MC10, INC. | |
8 | B493MC0011 | MC-0011 | MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493B MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05, B493MC0009 | Kintinuum™ | MC10, INC. | |
9 | 10850390007243 | PrimusRS | A very versatile rehabilitation device for upper extremity and lower extremity s A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions. | PrimusRS | BTE TECHNOLOGIES, INC. | |
10 | 10850390007236 | Primus+ | A very versatile rehabilitation device for upper extremity and lower extremity s A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions. | Primus | BTE TECHNOLOGIES, INC. | |
11 | 08717524641061 | 925909 | 965920 Excalibur Sport PFM | Lode B.V. | LODE B.V. | |
12 | 08717524641054 | 925900 | 965910 Excalibur Sport | Lode B.V. | LODE B.V. | |
13 | 08717524640712 | 969900 | 969900 Corival Recumbent cpet | Lode B.V. | LODE B.V. | |
14 | 08717524640705 | 969901 | 969901 Corival Recumbent rehab | Lode B.V. | LODE B.V. | |
15 | 08717524640699 | 960903 | 960903 Corival pediatric | Lode B.V. | LODE B.V. | |
16 | 08717524640620 | 967941 | 967941 Angio imaging - with stress support ultrasound (110V) | Lode B.V. | LODE B.V. | |
17 | 08717524640613 | 967940 | 967941 Angio imaging - with stress support ultrasound (110V) | Lode B.V. | LODE B.V. | |
18 | 08717524640576 | 967925 | 967925 Angio rehab fixation set | Lode B.V. | LODE B.V. | |
19 | 08717524640569 | 967924 | 967924 Angio rehab automatic stand | Lode B.V. | LODE B.V. | |
20 | 08717524640552 | 967923 | 967903 Angio cpet electrical wall fixation | Lode B.V. | LODE B.V. | |
21 | 08717524640545 | 967922 | 967922 Angio rehab static wall fixation | Lode B.V. | LODE B.V. | |
22 | 08717524640521 | 967905 | 967905 Angio imaging fixation set | Lode B.V. | LODE B.V. | |
23 | 08717524640514 | 967904 | 967904 Angio cpet automatic stand | Lode B.V. | LODE B.V. | |
24 | 08717524640507 | 967903 | 967903 Angio cpet electrical wall fixation | Lode B.V. | LODE B.V. | |
25 | 08717524640491 | 967902 | 967902 Angio cpet static wall fixation | Lode B.V. | LODE B.V. | |
26 | 08717524640484 | 967900 | 967900 angio cpet single set | Lode B.V. | LODE B.V. | |
27 | 08717524640392 | 937901 | 937901 MRI Ergometer Pedal | Lode B.V. | LODE B.V. | |
28 | 08717524640224 | 925910 | 925910 Brachumera Sport PFM | Lode B.V. | LODE B.V. | |
29 | 08717524640217 | 925901 | 925901 Brachumera Sport | Lode B.V. | LODE B.V. | |
30 | 08717524640200 | 925909 | 925909 Excalibur Sport PFM | Lode B.V. | LODE B.V. | |
31 | 08717524640194 | 925900 | 925900 Excalibur Sport | Lode B.V. | LODE B.V. | |
32 | 08717524640187 | 929900 | 929900 Corival Recumbent | Lode B.V. | LODE B.V. | |
33 | 08717524640057 | 960912 | 960912 Corival oem | Lode B.V. | LODE B.V. | |
34 | 08717524640033 | 960901 | 960901 Corival rehab | Lode B.V. | LODE B.V. | |
35 | 08717524640026 | 960900 | 960900 Corival cpet | Lode B.V. | LODE B.V. | |
36 | 08051122041091 | SHWM01SW1 | Showmotion software can be used to control motion sensors hardware in order to t Showmotion software can be used to control motion sensors hardware in order to track kinematics of upper/lower body by means of specific biomechanical protocols. Showmotion software can also be used as a stand-alone system when opening a subject's database, playing back previously recorded analyses, and when generating specific reports or comparison analyses. In this configuration there is no need to connect with the hardware sensors. | Software web Showmotion | NCS LAB SRL | |
37 | 08051122041084 | SHWM01S3 | The Showmotion SPINE 3 kit includes 3 WISE sensors, a GATEWAY receiver, elastic The Showmotion SPINE 3 kit includes 3 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the spine and the head. | SPINE KIT – 3 WISE | NCS LAB SRL | |
38 | 08051122041077 | SHWM01S2 | The Showmotion SPINE 2 kit includes 2 WISE sensors, a GATEWAY receiver, elastic The Showmotion SPINE 2 kit includes 2 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the spine. | SPINE KIT – 2 WISE | NCS LAB SRL | |
39 | 08051122041060 | SHWM01T12 | The Showmotion TOTAL 12 kit includes 12 WISE sensors, a GATEWAY receiver, elasti The Showmotion TOTAL 12 kit includes 12 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the total body. | TOTAL BODY KIT – 12 WISE | NCS LAB SRL | |
40 | 08051122041053 | SHWM01L8 | The Showmotion LOWER 8 kit includes 8 WISE sensors, a GATEWAY receiver, elastic The Showmotion LOWER 8 kit includes 8 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the lower district. | LOWER LIMB KIT – 8 WISE | NCS LAB SRL | |
41 | 08051122041046 | SHWM01L6 | The Showmotion LOWER 6 kit includes 6 WISE sensors, a GATEWAY receiver, elastic The Showmotion LOWER 6 kit includes 6 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the lower district. | LOWER LIMB KIT – 6 WISE | NCS LAB SRL | |
42 | 08051122041039 | SHWM01U7 | The Showmotion UPPER 7 kit includes 7 WISE sensors, a GATEWAY receiver, elastic The Showmotion UPPER 7 kit includes 7 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the upper district. | UPPER LIMB KIT – 7 WISE | NCS LAB SRL | |
43 | 08051122041022 | SHWM01U5 | The Showmotion UPPER 5 kit includes 5 WISE sensors, a GATEWAY receiver, elastic The Showmotion UPPER 5 kit includes 5 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the upper district. | UPPER LIMB KIT – 5 WISE | NCS LAB SRL | |
44 | 08051122041015 | GTWY01 | The GATEWAY is a 2.4 GHz wireless receiver that communicates with the WISE inert The GATEWAY is a 2.4 GHz wireless receiver that communicates with the WISE inertial sensor. | Gateway | NCS LAB SRL | |
45 | 08051122041008 | WISE01 | The WISE is a magnetic and inertial unit including 3D accelerometers, gyroscopes The WISE is a magnetic and inertial unit including 3D accelerometers, gyroscopes and magnetometers. | WISE (wireless inertial sensor equipment) | NCS LAB SRL | |
46 | 07290016986136 | PD-810 (Mindset) | VRReliever PD-810 | The PD-810 ("Mindset") is intended to assist in relaxation and self-management o The PD-810 ("Mindset") is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation andrelaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The PD-810 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The PD-810 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. | VRReliever | XR HEALTH IL LTD |
47 | 07290016986129 | MD-710 (Relax8) | The MD-710 ("Relax8") is intended to assist in relaxation and self-management of The MD-710 ("Relax8") is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation and relaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The MD-710 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The MD-710 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. MD-710 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment. | VRReliever | XR HEALTH IL LTD | |
48 | 07290016986099 | N-140 (Rotate) | A software-only medical device intended for cervical region rehabilitation. The A software-only medical device intended for cervical region rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The N-140 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. N-140 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment. | VRPhysio | XR HEALTH IL LTD | |
49 | 07290016986082 | MT-220 (Balloon Blast) | A software-only medical device intended for upper extremity and full body rehabi A software-only medical device intended for upper extremity and full body rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The MT-220 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MT-220 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment. | VRPhysio | XR HEALTH IL LTD | |
50 | 07290016986075 | MC-320 (Color Match) | A software-only medical device intended for motor-cognitive rehabilitation. The A software-only medical device intended for motor-cognitive rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of motor-cognitive exercises according to their treating medical practitioner's guidelines. The MC-320 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MC-320 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment. | VRCogni | XR HEALTH IL LTD |