OCF · Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
Neurology · 21 CFR 882.5890 · Class 2
Overview
| Product Code | OCF |
|---|---|
| Device Name | Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K900759 | POLY-OP (TM) | Nu-Gyn-Tek, Inc. | May 24, 1990 | SESE |
Top Applicants
- Nu-Gyn-Tek, Inc. — 1 clearance
