Identity
- Trade Name
- VRPhysio FDA UDI
- Generic Name
- Biomechanical function analysis/interactive rehabilitation system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- N-140 (Rotate) FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016986099 FDA UDI
- FDA Product Code
- ISD FDA UDI
- GMDN Term
- Biomechanical function analysis/interactive rehabilitation system 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: Biomechanical function analysis/rehabilitation softwareBiomechanical function analysis/interactive rehabilitation system
VRPhysio by Xr Health Il Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biomechanical function analysis/interactive rehabilitation system.
- OmniME — ACCELERATED CARE PLUS CORP. · Class I
- OmnisEMG — ACCELERATED CARE PLUS CORP. · Class II
- OmniFlow Therapy System — ACCELERATED CARE PLUS CORP. · Class I
- Waya Rehab — WELLOVATE LLC · Class II
- CAPS — VESTIBULAR TECHNOLOGIES, LLC · Class I
- mTrigger — MTRIGGER, LLC · Class II
- VRPhysio — XR HEALTH IL LTD · Class II
- VRCogni — 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 4808d6ad-e039-411f-8203-52ee1175e841 34 fields · synced May 30, 2026