K110716 is an FDA 510(k) clearance for the EVERYWAY LOW BACK PAIN RELIEF SYSTEM. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Everyway Medical Instruments Co.,Ltd (Taipei Hsien, TW). The FDA issued a Cleared decision on October 18, 2011, 217 days after receiving the submission on March 15, 2011.
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 | K110716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2011 |
| Decision Date | October 18, 2011 |
| Days to Decision | 217 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 |