K230829 is an FDA 510(k) clearance for the TENS7000 Rechargeable (Model:TENS7000 Rechargeable). This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Chongqing Rob Linka Science and Technology Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on April 26, 2023, 30 days after receiving the submission on March 27, 2023.
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 | K230829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2023 |
| Decision Date | April 26, 2023 |
| Days to Decision | 30 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 |