Identity
- Trade Name
- SaeboVR FDA UDI
- Generic Name
- Virtual-display rehabilitation system, non-supportive, clinical FDA UDI
- Device Name
- A software system used with the Microsoft Kinect intended to be used to support repetitive task practice for rehabilitation of adults under supervision of a medical professional in a clinical or home setting. The system includes simulated activities of daily living (ADLs) for the upper extremity with audiovisual feedback & graphic movement representations for patients as well as patient performance metrics for the medical professional. FDA UDI
- Model / Reference
- SaeboVR-1 FDA UDI
- Description
- A software system used with the Microsoft Kinect intended to be used to support repetitive task practice for rehabilitation of adults under supervision of a medical professional in a clinical or home setting. The system includes simulated activities of daily living (ADLs) for the upper extremity with audiovisual feedback & graphic movement representations for patients as well as patient performance metrics for the medical professional. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863090000400 FDA UDI
- FDA Product Code
- LXJ 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Virtual-display rehabilitation system, non-supportive, clinical
SaeboVR by Virtual Therapy Solutions, Llc. — 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
- Virtual Therapy Solutions, Llc.
Sources (1)
- FDA UDI 7f8f8192-d2d0-4f8c-b24d-526227597301 33 fields · synced May 30, 2026