TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)

Stimulator, Nerve, Transcutaneous, Over-the-counter

Dongguan Bohuikang Technology Co.,Ltd

The following data is part of a premarket notification filed by Dongguan Bohuikang Technology Co.,ltd with the FDA for Tens&ems Stimulator (model: Kres100d, Kres1010, Kres1020, Kres1080).

Pre-market Notification Details

Device IDK213788
510k NumberK213788
Device Name:TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Dongguan Bohuikang Technology Co.,Ltd 5th Floor,No 5, Second Street,Huaide Shui Xiang New Strict, Humen Town Dongguan,  CN 523165
ContactRihua Meng
CorrespondentJett Lee
Guangdong Jianda Medical Technology Co., Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou,  CN 510000
Product CodeNUH  
Subsequent Product CodeIPF
Subsequent Product CodeNGX
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-06
Decision Date2022-05-06

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