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 | K150995 |
| 510k Number | K150995 |
| Device Name: | Electronic Pulse Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | SHENZHEN JINGKEHUI ELECTRONIC CO., LTD 5F, BUILDING 12, HENGMINGZHU INDUSTRIAL PARK, XIANGXING ROAD SHAJING, BAOAN Shenzhen, CN 518104 |
| Contact | Pu Jiang |
| Correspondent | Bill Quanqin Dai BILL QUANQIN DAI 23541 COYOTE SPRING DRIVE Diamond Bar, CA 91765 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-07-06 |