JFA
12 FDA 510(k) clearances · Product code
29 daysmedian time to decision
289 days90th percentile
12clearances measured
FDA profile
- Official device name
- Exerciser, Finger, Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5410
- Medical specialty
- Physical Medicine
- Adverse events (MAUDE)
- 2000: 1
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 |
|---|---|---|
| THERMAFLEX, MODEL SD 55 C.P.M.H. (K945803) | Burke Neutech, Inc. | 1995-05-11 |
| JACE MODEL H440 HAND CPM DEVICE (K931016) | Jace Systems, Inc. | 1994-06-22 |
| HAND THERAPY ASSOST (K933418) | Bardon Ent., Inc. | 1994-04-28 |
| JACE MODEL PM-410 HAND CPM DEVICE (K921351) | Jace Systems, Inc. | 1992-05-04 |
| MOBILIMB H3 HAND CPM UNIT (K900794) | Toronto Medical Corp. | 1990-03-02 |
| DANNIFLEX CPM 880(TM) (K900581) | Buckman Co., Inc. | 1990-02-20 |
| TORONTO/MOBILIMB HAND C.P.M. (K880686) | Toronto Medical Corp. | 1988-02-26 |
| MOBILIMB HAND C.P.M. UNIT (K880336) | Toronto Medical Corp. | 1988-02-16 |
| ACE AIM - CPM HAND UNIT (K860714) | Buckman Co., Inc. | 1986-03-27 |
| MOBILIMB HAND UNIT (K844033) | Danninger Medical Technology, Inc. | 1984-11-27 |
| SUTTER CPM 5000 (K830974) | Sutter Biomedical, Inc. | 1983-04-12 |
| BURNETT-KETCHUM DYNAMIC HAND EXERCISER (K790527) | Maddak, Inc. | 1979-03-22 |
Track JFA automatically
Every clearance here is in the API, with alerts when new ones post.