Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K200561 |
Device Name |
StimPlus Patch, StimPlus Patch, StimPlus Patch |
Applicant |
JKH Health Co., LTD |
4-5F, Building 12, Hengmingzhu Ind. Park, Tongfuyu Ind. Area |
Shajing, Baoan |
Shenzhen,
CN
518104
|
|
Applicant Contact |
Pu Jiang |
Correspondent |
JKH Health Co., LTD |
4-5F, Building 12, Hengmingzhu Ind. Park, Tongfuyu Ind. Area |
Shajing, Baoan |
Shenzhen,
CN
518104
|
|
Correspondent Contact |
Pu Jiang |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/04/2020 |
Decision Date | 07/01/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|