Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
Device Facts
| Record ID | K221384 |
|---|---|
| Device Name | Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 |
| Applicant | Hivox Biotek, Inc. |
| Product Code | NUH · Neurology |
| Decision Date | Jun 11, 2022 |
| Decision | SESE |
| Submission Type | Special |
| 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.
