Incontinence Probe

Stimulator, Electrical, Non-implantable, For Incontinence

Shenzhen Med-link Electronics Tech Co, Ltd

The following data is part of a premarket notification filed by Shenzhen Med-link Electronics Tech Co, Ltd with the FDA for Incontinence Probe.

Pre-market Notification Details

Device IDK210441
510k NumberK210441
Device Name:Incontinence Probe
ClassificationStimulator, Electrical, Non-implantable, For Incontinence
Applicant Shenzhen Med-link Electronics Tech Co, Ltd 4th And 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community Dalang Street Shenzhen,  CN 518109
ContactYongfen Yang
CorrespondentYongfen Yang
Shenzhen Med-link Electronics Tech Co, Ltd 4th And 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community Dalang Street Shenzhen,  CN 518109
Product CodeKPI  
CFR Regulation Number876.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-12
Decision Date2021-09-17

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