Biofeedback Nerve And Muscle Stimulator

Stimulator, Electrical, Non-implantable, For Incontinence

Shenzhen Konmed Technology Co.,Ltd.

The following data is part of a premarket notification filed by Shenzhen Konmed Technology Co.,ltd. with the FDA for Biofeedback Nerve And Muscle Stimulator.

Pre-market Notification Details

Device IDK220161
510k NumberK220161
Device Name:Biofeedback Nerve And Muscle Stimulator
ClassificationStimulator, Electrical, Non-implantable, For Incontinence
Applicant Shenzhen Konmed Technology Co.,Ltd. 601, Building B4, Shenchengtou Creative Factory Life Science Park, Julongshan A Road Shenzhen,  CN 518118
ContactShuiShan Yin
CorrespondentCassie Lee
Guangzhou Glomed Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510530
Product CodeKPI  
CFR Regulation Number876.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-20
Decision Date2022-07-20

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