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

    Biofeedback Nerve and Muscle Stimulator

    K Number: K202648 · Decision Dec 8, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    7
    Review Days
    88

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    Basic Information

    Device Name
    Biofeedback Nerve and Muscle Stimulator
    K Number
    K202648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Konmed Technology Co., Ltd.
    Date Received
    September 11, 2020
    Decision Date
    December 8, 2020
    Product Code
    IPF
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IPF Stimulator, Muscle, Powered

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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
    K163288 Pelvifine Pelvic Muscle Trainer
    K171722 Electrodes with snap / Electrodes with pigtail
    K171721 Electrodes with silver conductive