JFA — Exerciser, Finger, Powered Class I
FDA product code JFA covers "Exerciser, Finger, Powered", a Class I medical device regulated under 21 CFR 890.5410. Submissions are reviewed by the Physical Medicine panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JFA
- Device Class
- Class I
- Regulation Number
- 890.5410
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K945803 | burke neutech | THERMAFLEX, MODEL SD 55 C.P.M.H. | May 11, 1995 |
| K931016 | jace systems | JACE MODEL H440 HAND CPM DEVICE | June 22, 1994 |
| K933418 | bardon ent | HAND THERAPY ASSOST | April 28, 1994 |
| K921351 | jace systems | JACE MODEL PM-410 HAND CPM DEVICE | May 4, 1992 |
| K900794 | toronto medical | MOBILIMB H3 HAND CPM UNIT | March 2, 1990 |
| K900581 | buckman co | DANNIFLEX CPM 880(TM) | February 20, 1990 |
| K880686 | toronto medical | TORONTO/MOBILIMB HAND C.P.M. | February 26, 1988 |
| K880336 | toronto medical | MOBILIMB HAND C.P.M. UNIT | February 16, 1988 |
| K860714 | buckman co | ACE AIM - CPM HAND UNIT | March 27, 1986 |
| K844033 | danninger medical technology | MOBILIMB HAND UNIT | November 27, 1984 |
| K830974 | sutter biomedical | SUTTER CPM 5000 | April 12, 1983 |
| K790527 | maddak | BURNETT-KETCHUM DYNAMIC HAND EXERCISER | March 22, 1979 |