The following data is part of a premarket notification filed by Jkh Health Co., Ltd. with the FDA for Electronic Pulse Stimulator Model: Pl-029k12 And Pl-029k13.
| Device ID | K162517 |
| 510k Number | K162517 |
| Device Name: | Electronic Pulse Stimulator Model: PL-029K12 And PL-029K13 |
| 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 | IRT |
| 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 | 2016-09-09 |
| Decision Date | 2017-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855944007427 | K162517 | 000 |
| 10855944007663 | K162517 | 000 |
| 10810038633944 | K162517 | 000 |
| 10810038634361 | K162517 | 000 |