Device
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...
Manufacturer
XR HEALTH IL LTD
XR HEALTH IL LTD
Model: VRGC-940 (GameChange)
DI: 07290016986204
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cb793b52-8366-4f64-86f0-ee10cc07887c
Distribution Status:
In Commercial Distribution
DUNS Number:
531893653
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07290016986204
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64245
Name: Hypnotherapy virtual reality software
Definition:
A virtual reality software program intended to be used with an appropriate off-the-shelf device in conjunction with a virtual reality headset (not included) to help reduce stress/anxiety by providing a patient with immersive imagery/sounds for relaxation hypnosis. It may be intended to sedate a patient or assist pain therapies. It is not intended to treat affective/mood disorders. It is intended to be used by patients in clinical settings, or at home under clinician consultation.
FDA Product Codes
ISD
Exerciser, Measuring