Identity
- Trade Name
- VRCogni FDA UDI
- Generic Name
- Biomechanical function analysis/interactive rehabilitation system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MC-320 (Color Match) FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016986075 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
VRCogni 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
- VRPhysio — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xr Health Il Ltd
Sources (1)
- FDA UDI ca2ba2f7-b2e2-4914-9069-f37f84f56f86 34 fields · synced May 29, 2026