FDA product code JFA: Exerciser, Finger, Powered
JFA is the FDA product code for exerciser, finger, powered. It is a Class I device, regulated under 21 CFR 890.5410 and reviewed by the Physical Medicine panel. FDA has cleared 12 510(k) submissions under JFA, from 8 different applicants. The average 510(k) review took 94 days (median 25).
Classification
| Field | Value |
|---|---|
| Device name | Exerciser, Finger, Powered |
| Device class | Class I |
| Regulation | 21 CFR 890.5410 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JFA clearance
Top JFA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Toronto Medical Corp. | 3 | 1990-03-02 |
| Jace Systems, Inc. | 2 | 1994-06-22 |
| Buckman Co., Inc. | 2 | 1990-02-20 |
| Burke Neutech, Inc. | 1 | 1995-05-11 |
| Bardon Ent., Inc. | 1 | 1994-04-28 |
3 more applicants have JFA clearances. See the full list in Caduvo.
Most recent JFA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945803 | Burke Neutech, Inc. | THERMAFLEX, MODEL SD 55 C.P.M.H. | 1995-05-11 | 164 |
| K931016 | Jace Systems, Inc. | JACE MODEL H440 HAND CPM DEVICE | 1994-06-22 | 481 |
| K933418 | Bardon Ent., Inc. | HAND THERAPY ASSOST | 1994-04-28 | 289 |
| K921351 | Jace Systems, Inc. | JACE MODEL PM-410 HAND CPM DEVICE | 1992-05-04 | 46 |
| K900794 | Toronto Medical Corp. | MOBILIMB H3 HAND CPM UNIT | 1990-03-02 | 10 |
Recalls for JFA devices
openFDA lists no recalls for product code JFA.
Frequently asked questions
What is FDA product code JFA?
JFA is the FDA product code for exerciser, finger, powered. It is a Class I device, regulated under 21 CFR 890.5410 and reviewed by the Physical Medicine panel.
What device class is JFA?
Class I, regulation 21 CFR 890.5410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JFA?
Across 12 cleared submissions the average was 94 days from receipt to decision (median 25).
Which companies have the most JFA clearances?
Toronto Medical Corp. (3); Jace Systems, Inc. (2); Buckman Co., Inc. (2); Burke Neutech, Inc. (1); Bardon Ent., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JFA
- Run a recall and safety report across every JFA manufacturer
- Watch product code JFA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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