StimPlus Patch, StimPlus Patch, StimPlus Patch

Stimulator, Nerve, Transcutaneous, Over-the-counter

JKH Health Co., LTD

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.

Pre-market Notification Details

Device IDK200561
510k NumberK200561
Device Name:StimPlus Patch, StimPlus Patch, StimPlus Patch
ClassificationStimulator, 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
ContactPu Jiang
CorrespondentPu Jiang
JKH Health Co., LTD 4-5F, Building 12, Hengmingzhu Ind. Park, Tongfuyu Ind. Area Shajing, Baoan Shenzhen,  CN 518104
Product CodeNUH  
Subsequent Product CodeIRT
Subsequent Product CodeNGX
Subsequent Product CodeNYN
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-04
Decision Date2020-07-01

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