K141978 is an FDA 510(k) clearance for the MAXPOWER RELIEF. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Omron Healthcare, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on December 3, 2014, 135 days after receiving the submission on July 21, 2014.
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 | K141978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2014 |
| Decision Date | December 03, 2014 |
| Days to Decision | 135 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 |