Identity
- Trade Name
- EnGauge Physical Rehabilitation System FDA UDI
- Generic Name
- Virtual-display rehabilitation system, non-supportive, clinical FDA UDI
- Device Name
- Verity XR EnGauge Physical Rehabilitation System is an Extended Reality software platform that augments physical rehabilitation through exercise gamification incorporating biofeedback, kinematic data reporting, and immersive learning. The EnGauge Physical Rehabilitation System software readily integrates with existing Extended Reality hardware and peripherals to provide an integrated physical rehabilitation system. FDA UDI
- Model / Reference
- VXRE-01 FDA UDI
- Description
- Verity XR EnGauge Physical Rehabilitation System is an Extended Reality software platform that augments physical rehabilitation through exercise gamification incorporating biofeedback, kinematic data reporting, and immersive learning. The EnGauge Physical Rehabilitation System software readily integrates with existing Extended Reality hardware and peripherals to provide an integrated physical rehabilitation system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008232304 FDA UDI
- FDA Product Code
- QKC FDA UDI
- GMDN Term
- Virtual-display rehabilitation system, non-supportive, clinical 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Virtual-display rehabilitation system, non-supportive, clinical
EnGauge Physical Rehabilitation System by Verity Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Verity Technologies
Sources (1)
- FDA UDI 2c00e0a3-5d47-4a00-9ebe-e756727b5d30 34 fields · synced May 31, 2026