Everyway Incontinence Stimulation System

Stimulator, Electrical, Non-implantable, For Incontinence

EVERYWAY MEDICAL INSTRUMENT CO., LTD.

The following data is part of a premarket notification filed by Everyway Medical Instrument Co., Ltd. with the FDA for Everyway Incontinence Stimulation System.

Pre-market Notification Details

Device IDK161349
510k NumberK161349
Device Name:Everyway Incontinence Stimulation System
ClassificationStimulator, Electrical, Non-implantable, For Incontinence
Applicant EVERYWAY MEDICAL INSTRUMENT CO., LTD. 3FL., NO. 5, LANE 155, SECTION 3, PEISHEN RD. Shenkeng Dist, New Taipei City,  CN 22203
ContactRobert Tu
CorrespondentRobert Tu
EVERYWAY MEDICAL INSTRUMENT CO., LTD. 3FL., NO. 5, LANE 155, SECTION 3, PEISHEN RD. Shenkeng Dist, New Taipei City,  CN 22203
Product CodeKPI  
CFR Regulation Number876.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-16
Decision Date2017-07-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719871189092 K161349 000
04719871185049 K161349 000
04719871185025 K161349 000
04719871184950 K161349 000
04719871189238 K161349 000
04719871189108 K161349 000

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