Simulator II Sim II 03
Simulator II Sim II 03 is a biomechanical function analysis system (FDA Class I; FDA product code BXB, Exerciser, Powered) made by Bte Technologies, Inc., cleared under FDA 510(k) K800007 on 21 Jan 1980 and listed in FDA GUDID since 25 Aug 2016 (UDI-DI 10850390007137), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10850390007137 | Date25 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK800007 | Date21 Jan 1980 | StatusActive |
Official records
- AccessGUDID record 10850390007137
- FDA 510(k) database K800007
Across registries
- FDA 510(k) K800007 decided 21 Jan 1980 Active
- FDA GUDID UDI-DI 10850390007137 listed 25 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K800007
- Listed FDA GUDID 10850390007137
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Simulator II
- Generic name
- Biomechanical function analysis system, force-testing, stationary
- Model / reference
- Sim II 03
- Primary DI / UDI-DI
- 10850390007137
- 510(k) Number
- FDA product code
- BXB
- GMDN term
- Biomechanical function analysis system, force-testing, stationary
- Device class
- Class I
- Regulation number
- 890.5380
- GUDID distribution status
- In Commercial Distribution
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