Identity
- Trade Name
- PrimusRS FDA UDI
- Generic Name
- Biomechanical function analysis system, force-testing, stationary FDA UDI
- Device Name
- A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions. FDA UDI
- Model / Reference
- PrimusRS FDA UDI
- Description
- A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850390007243 FDA UDI
- 510(k) Number
- K933611 FDA UDI
- FDA Product Code
- ISD FDA UDI
- GMDN Term
- Biomechanical function analysis system, force-testing, stationary 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biomechanical function analysis system, force-testing, stationary
PrimusRS by Bte Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biomechanical function analysis system, force-testing, stationary.
- EvalTech — BTE TECHNOLOGIES · Class II
- Simulator II — BTE TECHNOLOGIES · Class I
- Prism — BTE TECHNOLOGIES · Class II
- Provider Test Kit (PTK) — BTE TECHNOLOGIES · Class II
- Simulator II — BTE TECHNOLOGIES · Class I
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
- Bte Technologies
Sources (1)
- FDA UDI 57e55c32-d0e6-4815-9d76-b43de2aca601 36 fields · synced Jun 8, 2026