K241678 is an FDA 510(k) clearance for the TENS & EMS Stimulator (MHD-1083). This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Shenzhen Minghuangda Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 9, 2024, 90 days after receiving the submission on June 11, 2024.
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 | K241678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2024 |
| Decision Date | September 09, 2024 |
| Days to Decision | 90 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 |