K153045 is an FDA 510(k) clearance for the SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator. This device is classified as a Stimulator, Nerve, Battery-powered (Class II - Special Controls, product code BXN).
Submitted by Easy Med Instrument Co., Ltd. (Daliang, Shunde, Foshan, CN). The FDA issued a Cleared decision on May 13, 2016, 207 days after receiving the submission on October 19, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K153045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2015 |
| Decision Date | May 13, 2016 |
| Days to Decision | 207 days |
| Submission Type | Special |
| 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 |