K220997 is an FDA 510(k) clearance for the Wireless TENS/EMS, Bruno, Aela. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Zmi Elecronics , Ltd. (Kaohsiung, TW). The FDA issued a Cleared decision on September 1, 2022, 150 days after receiving the submission on April 4, 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 | K220997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2022 |
| Decision Date | September 01, 2022 |
| Days to Decision | 150 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 |