K130802 is an FDA 510(k) clearance for the OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060). This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on September 16, 2013, 178 days after receiving the submission on March 22, 2013.
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 | K130802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2013 |
| Decision Date | September 16, 2013 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| 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 |