BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Everyway Incontinence Stimulation System

    K Number: K161349 · Decision Jul 7, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    2
    Review Days
    417

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    Basic Information

    Device Name
    Everyway Incontinence Stimulation System
    K Number
    K161349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Everyway Medical Instrument Co., Ltd.
    Date Received
    May 16, 2016
    Decision Date
    July 7, 2017
    Product Code
    KPI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

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    Other Clearances by Everyway Medical Instrument Co., Ltd.

    K Number Device Name
    K162744 Everyway OTC EMS, Model EV-805