The following data is part of a premarket notification filed by Easymed Instrument Co., Ltd. with the FDA for Sunstim Peripheral Nerve Stimulator/sunstim Plus Peripheral Nerve Stimulator.
| Device ID | K153045 |
| 510k Number | K153045 |
| Device Name: | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | EASYMED INSTRUMENT CO., LTD. 5/F-6/F, BLK A, GUPO GONGMAO BLD FENGXIN ROAD, FENGXIANG INDUSTRIAL DISTRICT Daliang, Shunde, Foshan, CN 528300 |
| Contact | Jeffery Wu (tingjie Wu) |
| Correspondent | Jeffery Wu (tingjie Wu) EASYMED INSTRUMENT CO., LTD. 5/F-6/F, BLK A, GUPO GONGMAO BLD FENGXIN ROAD, FENGXIANG INDUSTRIAL DISTRICT Daliang, Shunde, Foshan, CN 528300 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-19 |
| Decision Date | 2016-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889483171844 | K153045 | 000 |
| 10889483171127 | K153045 | 000 |
| 10889483000014 | K153045 | 000 |