FRK
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Chair, Examination And Treatment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6140
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2013: 71 · 2014: 41 · 2015: 29 · 2016: 20 · 2017: 22 · 2018: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| JEDMED J-II CHAIR (K896275) | Jedmed Instrument Co. | 1989-12-18 |
| ULTICARE 2500 TREATMENT CHAIR (K791016) | American Health Care Industries, Inc. | 1979-06-27 |
| COVER GARD (K790955) | Fem-Gard, Inc. | 1979-06-20 |
| HEEL GARD (K790954) | Fem-Gard, Inc. | 1979-06-20 |
Track FRK automatically
Every clearance here is in the API, with alerts when new ones post.