FDA Product Code
FDA Product Code JFA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5410
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K945803 | THERMAFLEX, MODEL SD 55 C.P.M.H. | Burke Neutech, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K931016 | JACE MODEL H440 HAND CPM DEVICE | Jace Systems, Inc. | 1994-06-22 | Traditional | PDF ↗ |
| K933418 | HAND THERAPY ASSOST | Bardon Ent., Inc. | 1994-04-28 | Traditional | PDF ↗ |
| K921351 | JACE MODEL PM-410 HAND CPM DEVICE | Jace Systems, Inc. | 1992-05-04 | Traditional | PDF ↗ |
| K900794 | MOBILIMB H3 HAND CPM UNIT | Toronto Medical Corp. | 1990-03-02 | Traditional | PDF ↗ |
| K900581 | DANNIFLEX CPM 880(TM) | Buckman Co., Inc. | 1990-02-20 | Traditional | PDF ↗ |
| K880686 | TORONTO/MOBILIMB HAND C.P.M. | Toronto Medical Corp. | 1988-02-26 | Traditional | PDF ↗ |
| K880336 | MOBILIMB HAND C.P.M. UNIT | Toronto Medical Corp. | 1988-02-16 | Traditional | PDF ↗ |
| K860714 | ACE AIM - CPM HAND UNIT | Buckman Co., Inc. | 1986-03-27 | Traditional | PDF ↗ |
| K844033 | MOBILIMB HAND UNIT | Danninger Medical Technology, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K830974 | SUTTER CPM 5000 | Sutter Biomedical, Inc. | 1983-04-12 | Traditional | PDF ↗ |
| K790527 | BURNETT-KETCHUM DYNAMIC HAND EXERCISER | Maddak, Inc. | 1979-03-22 | Traditional | PDF ↗ |
Product code JFA · Class I · Physical Medicine. Data: openFDA.