BIO TENS 601, 606 AND 608 (3000)
Device Facts
| Record ID | K912178 |
|---|---|
| Device Name | BIO TENS 601, 606 AND 608 (3000) |
| Applicant | Skylark Device Co., Ltd. |
| Product Code | GZJ · Neurology |
| Decision Date | Oct 25, 1991 |
| 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.