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

    Pelvifine Pelvic Muscle Trainer

    K Number: K163288 · Decision Jan 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    7
    Review Days
    422

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    Basic Information

    Device Name
    Pelvifine Pelvic Muscle Trainer
    K Number
    K163288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Konmed Technology Co., Ltd.
    Date Received
    November 22, 2016
    Decision Date
    January 18, 2018
    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 Shenzhen Konmed Technology Co., Ltd.

    K Number Device Name
    K260178 Pelvic Muscle Trainer (KM510, KM516B)
    K233576 Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)
    K220161 Biofeedback Nerve and Muscle Stimulator
    K202648 Biofeedback Nerve and Muscle Stimulator
    K171722 Electrodes with snap / Electrodes with pigtail
    K171721 Electrodes with silver conductive