OCF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5890
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
- FDA 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).
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| Record | Firm | Date |
|---|---|---|
| POLY-OP (TM) (K900759) | Nu-Gyn-Tek, Inc. | 1990-05-24 |
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Every clearance here is in the API, with alerts when new ones post.