K121743 is an FDA 510(k) clearance for the EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN. This device is classified as a Stimulator, Nerve, Battery-powered (Class II - Special Controls, product code BXN).
Submitted by Sunmed, LLC (Daliang, Shunde, Foshan, CN). The FDA issued a Cleared decision on March 28, 2013, 288 days after receiving the submission on June 13, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K121743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2012 |
| Decision Date | March 28, 2013 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BXN — Stimulator, Nerve, Battery-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2775 |