K221251 is an FDA 510(k) clearance for the Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C). This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Guangzhou Huakai Electronic Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on July 29, 2022, 88 days after receiving the submission on May 2, 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 | K221251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2022 |
| Decision Date | July 29, 2022 |
| Days to Decision | 88 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 |