K222879 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1). This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on January 24, 2023, 124 days after receiving the submission on September 22, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K222879 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2022 |
| Decision Date | January 24, 2023 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZJ - Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |