Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)

Stimulator, Nerve, Transcutaneous, Over-the-counter

Guangzhou Hua Kai Electronic Technology Co., Ltd.

The following data is part of a premarket notification filed by Guangzhou Hua Kai Electronic Technology Co., Ltd. with the FDA for Ems Foot Stimulator (model: Hk701, Hk701a, Hk701b, Hk701c).

Pre-market Notification Details

Device IDK221251
510k NumberK221251
Device Name:Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Guangzhou Hua Kai Electronic Technology Co., Ltd. 4th Floor, Building 8, No.39 Bi Gang Road, Dongqu Street, Huangpu District Guangzhou,  CN 510730
ContactCao Ke
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510000
Product CodeNUH  
Subsequent Product CodeIRT
Subsequent Product CodeNGX
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-02
Decision Date2022-07-29

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