The following data is part of a premarket notification filed by Sunmed Llc with the FDA for Easymed Peripheral Nerve Stimulator-sunstin.
| Device ID | K121743 |
| 510k Number | K121743 |
| Device Name: | EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | SUNMED LLC C/O EASYMED INSTRUMENTS CO,5/ -6/F,BLOCK A,GUPO GONGMAO BLDG FENGXIN RD, FENGXIANG INDUSTRIAL DISTRICT Daliang, Shunde, Foshan, CN 528300 |
| Contact | Wu Tingjie |
| Correspondent | Wu Tingjie SUNMED LLC C/O EASYMED INSTRUMENTS CO,5/ -6/F,BLOCK A,GUPO GONGMAO BLDG FENGXIN RD, FENGXIANG INDUSTRIAL DISTRICT Daliang, Shunde, Foshan, CN 528300 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-13 |
| Decision Date | 2013-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889483056523 | K121743 | 000 |
| 10889483171417 | K121743 | 000 |
| 10889483171424 | K121743 | 000 |
| 10889483171431 | K121743 | 000 |
| 10889483171448 | K121743 | 000 |
| 10889483171455 | K121743 | 000 |
| 10889483171462 | K121743 | 000 |
| 10889483171479 | K121743 | 000 |
| 10889483171486 | K121743 | 000 |
| 10889483005835 | K121743 | 000 |
| 10889483005842 | K121743 | 000 |
| 10889483005866 | K121743 | 000 |
| 10889483005873 | K121743 | 000 |
| 10889483005941 | K121743 | 000 |
| 10889483005958 | K121743 | 000 |
| 10889483055557 | K121743 | 000 |
| 10889483055564 | K121743 | 000 |
| 10889483056516 | K121743 | 000 |
| 10889483171394 | K121743 | 000 |