The following data is part of a premarket notification filed by Jkh Health Co.,ltd. with the FDA for Electronic Pulse Stimulator.
| Device ID | K153520 |
| 510k Number | K153520 |
| Device Name: | Electronic Pulse Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | JKH HEALTH CO.,LTD. 4-5F, Building 12, Hengmingzhu Ind. Park, Tongfuyu Ind. Area, Shajing, Baoan Shenzhen, CN 518104 |
| Contact | Pu Jiang |
| Correspondent | Bill Quanqin Dai BILL QUANQIN DAI 1142 S. DIAMOND BAR BLVD, #861 Diamond Bar, CA 91765 |
| Product Code | NUH |
| Subsequent Product Code | NGX |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-08 |
| Decision Date | 2016-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817746020915 | K153520 | 000 |
| 10810038630097 | K153520 | 000 |
| 10810038630080 | K153520 | 000 |
| 10810038632039 | K153520 | 000 |
| 10863696000375 | K153520 | 000 |
| 10858069007020 | K153520 | 000 |
| 10863696000399 | K153520 | 000 |
| 10810038634002 | K153520 | 000 |