FDA product code OCF: Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
OCF is the FDA product code for stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under OCF. The average 510(k) review took 97 days (median 97).
Definition
Electrical stimulation of nerves for relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). Relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief |
| Device class | Class II |
| Regulation | 21 CFR 882.5890 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OCF clearance
Top OCF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nu-Gyn-Tek, Inc. | 1 | 1990-05-24 |
Most recent OCF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900759 | Nu-Gyn-Tek, Inc. | POLY-OP (TM) | 1990-05-24 | 97 |
Recalls for OCF devices
openFDA lists no recalls for product code OCF.
Frequently asked questions
What is FDA product code OCF?
OCF is the FDA product code for stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel.
What device class is OCF?
Class II, regulation 21 CFR 882.5890. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCF?
Across 1 cleared submissions the average was 97 days from receipt to decision (median 97).
Which companies have the most OCF clearances?
Nu-Gyn-Tek, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OCF
- Run a recall and safety report across every OCF manufacturer
- Watch product code OCF 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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