Other products from "XR HEALTH IL LTD"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 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. ISD Exerciser, Measuring 2 VRReliever
2 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. ISD Exerciser, Measuring 2 VRPhysio
3 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. ISD Exerciser, Measuring 2 VRPhysio
4 07290016986068 CB-510 (Luna) The CB-510 ("Luna") is intended to assist in the mitigation of pain, hot flashes The CB-510 ("Luna") is intended to assist in the mitigation of pain, hot flashes and physical discomfort through distraction and supporting exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The CB-510 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The CB-510 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. CB-510 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment. ISD Exerciser, Measuring 2 VRReliever
5 07290016986143 AT-910 (A10tion) VRCBT AT-910 The AT-910 ("A10tion") is a is a virtual reality, immersive therapeuticapplicati The AT-910 ("A10tion") is a is a virtual reality, immersive therapeuticapplication, indicated to train and improve cognitive function of patients withdiagnosed ADHD. This application is a clinician- monitored program and should beconsidered for use as part of the therapeutic program that include clinician directedtherapyThis multidimensional training program application targetsattention, executive function and memory combined with motor activationthrough the use of games and entertainment features. PTY Computerized Cognitive Assessment Aid, Exempt 2 VRCBT
6 07290016986112 CT-620 (Memorize) A software-only medical device intended to aid mitigate or assess conditions rel A software-only medical device intended to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. The cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable guiding patients in the performance of various cognitive exercises, tracking and analyzing motion and movement kinematics and monitoring changes in patient's measurements over time.The CT-620 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. CT-620 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device. PTY Computerized Cognitive Assessment Aid, Exempt 2 VRCogni
7 07290016986105 CT-610 (Re-Act) A software-only medical device intended to aid mitigate or assess conditions rel A software-only medical device intended to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. The cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable guiding patients in the performance of various cognitive exercises, tracking and analyzing motion and movement kinematics and monitoring changes in patient's measurements over time.The CT-610 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. CT-610 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device. PTY Computerized Cognitive Assessment Aid, Exempt 2 VRCogni
8 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. ISD Exerciser, Measuring 2 VRCogni
9 07290016986006 N-110 (Aqua Clown) 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. ISD Exerciser, Measuring 2 VRPhysio
10 07290016986044 MC-310 (Color Match) A software-only medical device intended for upper extremity and full body conven A software-only medical device intended for upper extremity and full body conventional 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. ISD Exerciser, Measuring 2 VRPhysio
11 07290016986037 P-410 (Dot Track) A software-only medical device intended for cervical region and upper body extre A software-only medical device intended for cervical region and upper body extremities 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. ISD Exerciser, Measuring 2 VRPhysio
12 07290016986020 N-120 (Catch the Screen) 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. ISD Exerciser, Measuring 2 VRPhysio
13 07290016986013 MT-210 (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. ISD Exerciser, Measuring 2 VRPhysio
Other products with the same Product Code "ISD"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00853048008015 GT9X The GT9X is a body worn device that measures and records physical movement assoc The GT9X is a body worn device that measures and records physical movement associated with daily activity and sleep. The GT9X is intended for use in applications where quantifiable measurement and storage of physical movement is desired. ActiGraph ACTIGRAPH L.L.C.
2 00853048008008 wGT3X-BT The wGT3X-BT is a body worn device that measures and records physical movement a The wGT3X-BT is a body worn device that measures and records physical movement associated with daily activity and sleep. The wGT3X-BT is intended for use in applications where quantifiable measurement and storage of physical movement is desired. Actigraph ACTIGRAPH L.L.C.
3 00853023006180 MotionHealth2016.22 Cerner Motion Health CERNER CORPORATION
4 00851688007016 Lumbar Measuring exercise equipment MedX MEDX HOLDINGS, INC.
5 00850023837042 V2C ODHV2C The Opal DataHub is an accessory that extracts raw sensor data from the Opal V2C The Opal DataHub is an accessory that extracts raw sensor data from the Opal V2C sensors and uploads it to a remote server where the files are processed. Additionally, the Opal DataHub recharges the battery of the Opal V2C sensors. Opal DataHub ERESEARCHTECHNOLOGY, INC.
6 00850023837035 APV2C Access Point is an accessory that enables wireless streaming to a computer for t Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C. Access Point V2C ERESEARCHTECHNOLOGY, INC.
7 00850023837028 DSV2C Docking Station is an accessory that transfers the raw sensor data logged to a c 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 ERESEARCHTECHNOLOGY, INC.
8 00850023837011 V2C Opal V2C is a small Worn Monitor designed for documenting physical movement asso 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 ERESEARCHTECHNOLOGY, INC.
9 00815962020634 BITS-3355 Bioness Integrated Therapy System Version 3.0 Motion Sensor BITS Motion Sensor BIONESS INC.
10 00815962020627 BITS-3155 BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit Bioness Integrated Therapy System, BITS 3.0, BITS Balance BIONESS INC.
11 00815962020610 BITS-3055 Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS S Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit Bioness Integrated Therapy System, BITS 3.0, BITS Balance BIONESS INC.
12 00815948024250 RLY1S-A REAL y-Series, Edu Use REAL Immersive System PENUMBRA, INC.
13 00815948024243 RLY1V-A REAL y-Series, Eval Use REAL Immersive System PENUMBRA, INC.
14 00815948024236 RLY1-A REAL y-Series REAL Immersive System PENUMBRA, INC.
15 00815948024212 REAL1S-A REAL Immersive System, Edu Use REAL Immersive System PENUMBRA, INC.
16 00815948024205 REAL1V-A REAL Immersive System, Eval Use REAL Immersive System PENUMBRA, INC.
17 00815948022416 BND-A REAL System Bands REAL System Bands PENUMBRA, INC.
18 00815948021389 BND REAL Sensor Bands for the REAL Immersive System REAL Sensor Bands PENUMBRA, INC.
19 00815948021037 REAL1 REAL Immersive System REAL Immersive System PENUMBRA, INC.
20 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
21 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.
22 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.
23 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.
24 B493SW0043 SW-0043 Web application Kintinuum™ MC10, INC.
25 B493SW0042 SW-0042 Patient application for Android Kintinuum™ MC10, INC.
26 B493MC0016 MC-0016 Instructions for use Kintinuum™ MC10, INC.
27 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.
28 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.
29 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.
30 08717524641061 925909 965920 Excalibur Sport PFM Lode B.V. LODE B.V.
31 08717524641054 925900 965910 Excalibur Sport Lode B.V. LODE B.V.
32 08717524640712 969900 969900 Corival Recumbent cpet Lode B.V. LODE B.V.
33 08717524640705 969901 969901 Corival Recumbent rehab Lode B.V. LODE B.V.
34 08717524640699 960903 960903 Corival pediatric Lode B.V. LODE B.V.
35 08717524640620 967941 967941 Angio imaging - with stress support ultrasound (110V) Lode B.V. LODE B.V.
36 08717524640613 967940 967941 Angio imaging - with stress support ultrasound (110V) Lode B.V. LODE B.V.
37 08717524640576 967925 967925 Angio rehab fixation set Lode B.V. LODE B.V.
38 08717524640569 967924 967924 Angio rehab automatic stand Lode B.V. LODE B.V.
39 08717524640552 967923 967903 Angio cpet electrical wall fixation Lode B.V. LODE B.V.
40 08717524640545 967922 967922 Angio rehab static wall fixation Lode B.V. LODE B.V.
41 08717524640521 967905 967905 Angio imaging fixation set Lode B.V. LODE B.V.
42 08717524640514 967904 967904 Angio cpet automatic stand Lode B.V. LODE B.V.
43 08717524640507 967903 967903 Angio cpet electrical wall fixation Lode B.V. LODE B.V.
44 08717524640491 967902 967902 Angio cpet static wall fixation Lode B.V. LODE B.V.
45 08717524640484 967900 967900 angio cpet single set Lode B.V. LODE B.V.
46 08717524640392 937901 937901 MRI Ergometer Pedal Lode B.V. LODE B.V.
47 08717524640224 925910 925910 Brachumera Sport PFM Lode B.V. LODE B.V.
48 08717524640217 925901 925901 Brachumera Sport Lode B.V. LODE B.V.
49 08717524640200 925909 925909 Excalibur Sport PFM Lode B.V. LODE B.V.
50 08717524640194 925900 925900 Excalibur Sport Lode B.V. LODE B.V.