The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Electronic Pulse Stimulator.
| Device ID | K160508 |
| 510k Number | K160508 |
| Device Name: | Electronic Pulse Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. NO.9 SHUANGYUAN ROAD, BADACH HI-TECH ZONE SHIJINGSHAN DISTRICT Beijing, CN 100041 |
| Contact | Lei Chen |
| Correspondent | Lei Chen BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. NO.9 SHUANGYUAN ROAD, BADACH HI-TECH ZONE SHIJINGSHAN DISTRICT Beijing, CN 100041 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-24 |
| Decision Date | 2016-11-21 |
| Summary: | summary |