K161091 is an FDA 510(k) clearance for the STIMPOD NMS460 Nerve Stimulator. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Xavant Technology (Pty), Ltd. (Silverton, ZA). The FDA issued a Cleared decision on January 18, 2017, 275 days after receiving the submission on April 18, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K161091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2016 |
| Decision Date | January 18, 2017 |
| Days to Decision | 275 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |