K162392 is an FDA 510(k) clearance for the Avazzia. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Avazzia, Inc. (Dallas, US). The FDA issued a Cleared decision on May 12, 2017, 259 days after receiving the submission on August 26, 2016.
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 | K162392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2016 |
| Decision Date | May 12, 2017 |
| Days to Decision | 259 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 |