Identity
- Trade Name
- Simulator II FDA UDI
- Generic Name
- Biomechanical function analysis system, force-testing, stationary FDA UDI
- Device Name
- A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions. FDA UDI
- Model / Reference
- Sim II 5 FDA UDI
- Description
- A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850390007151 FDA UDI
- 510(k) Number
- K800007 FDA UDI
- FDA Product Code
- BXB FDA UDI
- GMDN Term
- Biomechanical function analysis system, force-testing, stationary FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5380 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
Simulator II by Bte Technologies — Class I — 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
- PrimusRS — BTE TECHNOLOGIES · Class II
- Provider Test Kit (PTK) — BTE TECHNOLOGIES · Class II
Cleared under the same submission
K800007 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Bte Technologies
Sources (1)
- FDA UDI 4116c815-d37e-49ff-bf95-4970b1503387 35 fields · synced May 30, 2026