K190009 is an FDA 510(k) clearance for the Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S). This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Hong Qiangxing (Shenzhen) Electronics Limited (Shenzhen, CN). The FDA issued a Cleared decision on December 2, 2019, 333 days after receiving the submission on January 3, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890. Temporary Relief Of Pain Due To Sore/aching Muscles.
| 510(k) Number | K190009 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2019 |
| Decision Date | December 02, 2019 |
| Days to Decision | 333 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NUH - Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |
| Definition | Temporary Relief Of Pain Due To Sore/aching Muscles |