The following data is part of a premarket notification filed by Jkh Health Co., Ltd with the FDA for Stimplus Patch, Stimplus Patch, Stimplus Patch.
| Device ID | K200561 |
| 510k Number | K200561 |
| Device Name: | StimPlus Patch, StimPlus Patch, StimPlus Patch |
| 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 | Pu Jiang JKH Health Co., LTD 4-5F, Building 12, Hengmingzhu Ind. Park, Tongfuyu Ind. Area Shajing, Baoan Shenzhen, CN 518104 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-04 |
| Decision Date | 2020-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06281769492150 | K200561 | 000 |
| 10810038631544 | K200561 | 000 |
| 10628176949212 | K200561 | 000 |
| 00628176949550 | K200561 | 000 |