K221092 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator Model: ST-304. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Shenzhen Future Electronic Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 13, 2022, 153 days after receiving the submission on April 13, 2022.
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 | K221092 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2022 |
| Decision Date | September 13, 2022 |
| Days to Decision | 153 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 |