Prism Prism1
Prism Prism1 is a biomechanical function analysis system (FDA Class II; FDA product code IKK, System, Isokinetic Testing And Evaluation) made by Bte Technologies, Inc., listed in FDA GUDID since 17 Jun 2022 (UDI-DI 10850390007380), registry data as of 8 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10850390007380 | Date17 Jun 2022 | StatusListed |
Official records
- AccessGUDID record 10850390007380
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Prism
- Generic name
- Biomechanical function analysis system, force-testing, stationary
- Model / reference
- Prism1
- Primary DI / UDI-DI
- 10850390007380
- FDA product code
- IKK
- GMDN term
- Biomechanical function analysis system, force-testing, stationary
- Device class
- Class II
- Regulation number
- 890.1925
- GUDID distribution status
- In Commercial Distribution
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