K112415 is an FDA 510(k) clearance for the LIFECARE ARM & LEG 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 21, 2011, 60 days after receiving the submission on August 22, 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 | K112415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2011 |
| Decision Date | October 21, 2011 |
| Days to Decision | 60 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 |