Identity
- Trade Name
- VRReliever FDA UDI
- Generic Name
- Mental health/function therapeutic software, screen-viewed FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MD-710 (Relax8) FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016986129 FDA UDI
- FDA Product Code
- ISD FDA UDI
- GMDN Term
- Mental health/function therapeutic software, screen-viewed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mental health/function therapeutic software, screen-viewedHypnotherapy virtual reality software
VRReliever by Xr Health Il Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hypnotherapy virtual reality software.
- VRBehavior — XR HEALTH IL LTD · Class II
- VRReliever — XR HEALTH IL LTD · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Xr Health Il Ltd
Sources (1)
- FDA UDI 05006511-1c23-4100-9dd5-12fb61fa05ec 34 fields · synced May 30, 2026