Unicare (K-UNICARE-USA)
Device Facts
| Record ID | K231053 |
|---|---|
| Device Name | Unicare (K-UNICARE-USA) |
| Applicant | Tenscare, Ltd. |
| Product Code | NUH · Neurology |
| Decision Date | Aug 18, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
Regulatory Classification
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.
