Electronic Pulse Stimulator

Stimulator, Nerve, Transcutaneous, Over-the-counter

SHENZHEN JINGKEHUI ELECTRONIC CO., LTD

The following data is part of a premarket notification filed by Shenzhen Jingkehui Electronic Co., Ltd with the FDA for Electronic Pulse Stimulator.

Pre-market Notification Details

Device IDK150995
510k NumberK150995
Device Name:Electronic Pulse Stimulator
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant SHENZHEN JINGKEHUI ELECTRONIC CO., LTD 5F, BUILDING 12, HENGMINGZHU INDUSTRIAL PARK, XIANGXING ROAD SHAJING, BAOAN Shenzhen,  CN 518104
ContactPu Jiang
CorrespondentBill Quanqin Dai
BILL QUANQIN DAI 23541 COYOTE SPRING DRIVE Diamond Bar,  CA  91765
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-15
Decision Date2015-07-06

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