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

    Keffort (MC-100, MC-100A)

    K Number: K213133 · Decision Apr 13, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    5
    Review Days
    198

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    Basic Information

    Device Name
    Keffort (MC-100, MC-100A)
    K Number
    K213133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oriental Inspiration Limited
    Date Received
    September 27, 2021
    Decision Date
    April 13, 2022
    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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