FDA.reportPublic FDA data

XR HEALTH IL LTD

GUDID#

XRBehavior - The VRSO-940 Step Out is a prescription only software application intended for users who experience anxiety or distress related to leaving their home or participating in everyday social environments. VRSO-940 provides immersive virtual environments and guided behavioral exercises designed to support users in practicing coping strategies and gradually engaging with common real-world situations. The program is intended to be used under the supervision of a healthcare professional as an adjunct to standard care. VRSO-940 does not diagnose, treat, or prevent any medical or psychiatric condition and does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.

XR HEALTH IL LTD

2026-05-14

XRBehavior - The VRGC-940 GameChange is a prescription only software application intended for users who experience anxiety or distress related to leaving their home or participating in everyday social environments. VRGC-940 provides immersive virtual environments and guided behavioral exercises designed to support users in practicing coping strategies and gradually engaging with common real-world situations. The program is intended to be used under the supervision of a healthcare professional as an adjunct to standard care. VRGC-940 does not diagnose, treat, or prevent any medical or psychiatric condition and does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.

XR HEALTH IL LTD

2026-05-04

VRCBT - "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. "

XR HEALTH IL LTD

2021-06-15

VRReliever - "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."

XR HEALTH IL LTD

2020-01-21

VRCogni - 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.

XR HEALTH IL LTD

2019-12-30

VRCogni - 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.

XR HEALTH IL LTD

2019-11-28

VRReliever - "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."

XR HEALTH IL LTD

2019-06-13

VRCogni - 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.

XR HEALTH IL LTD

2020-02-20

VRPhysio - 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.

XR HEALTH IL LTD

2019-10-16

VRPhysio - 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.

XR HEALTH IL LTD

2019-09-08

VRReliever - "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. "

XR HEALTH IL LTD

2021-06-15