Evaluator
Evaluator 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 25 Aug 2016 (UDI-DI 10850390007335), 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 | Number10850390007335 | Date25 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 10850390007335
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Biomechanical function analysis system, force-testing, portable
- Model / reference
- Evaluator
- Primary DI / UDI-DI
- 10850390007335
- FDA product code
- IKK
- GMDN term
- Biomechanical function analysis system, force-testing, portable
- Device class
- Class II
- Regulation number
- 890.1925
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code IKK (System, Isokinetic Testing And Evaluation).
- TEST ONE by Primed Products, Inc.
- BIODEX SYSTEM 2 AUTOPROGRAM by Biodex Corp.
- Bio-Coordinator System by Bio-Harmonizer, Inc.
- Multi-joint isokinetic training and testing system A8mini2 by Guangzhou Yikang Medical Equipment Industrial Co., Ltd
- Discipline II RTD by Physio Systems, Inc.
- Isostation Ankle/Subtalar Machine A-100 by Isotechnologies, Inc.
- THERA-Trainer lyra 01.XX.XX by medica - Medizintechnik GmbH
- SIMS CHAIR by Twin City Surgical, Inc.
- BTE Dynamic Lift by Baltimore Therapeutic Equipment Co.
- Lido Lift by Loredan Biomedical, Inc.