The following data is part of a premarket notification filed by Shenzhen Jingkehui Electronic Co., Ltd with the FDA for Electronic Pulse Stimulator.
| Device ID | K131921 |
| 510k Number | K131921 |
| Device Name: | ELECTRONIC PULSE STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | SHENZHEN JINGKEHUI ELECTRONIC CO., LTD 513 PIAZZA DR. UNIT B Mountain View, CA 94043 |
| Contact | Bill Dai |
| Correspondent | Bill Dai SHENZHEN JINGKEHUI ELECTRONIC CO., LTD 513 PIAZZA DR. UNIT B Mountain View, CA 94043 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-26 |
| Decision Date | 2013-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817746020397 | K131921 | 000 |
| 10850253007755 | K131921 | 000 |
| 00850253007130 | K131921 | 000 |
| 00850253007123 | K131921 | 000 |
| 10810038630110 | K131921 | 000 |
| 10810038630103 | K131921 | 000 |