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 |