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    K Number
    K132588
    Device Name
    ADHESIVE ELECTRODES
    Manufacturer
    TOP-RANK HEALTH CARE EQUIPMENT CO., LTD.
    Date Cleared
    2013-11-22

    (95 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOP-RANK HEALTH CARE EQUIPMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
    Device Description
    Adhesive electrodes are intended for use as the disposable, conductive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuancous Electrical Nerver Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use. The proposed device. Adhesive Electrode, is intended to be used with U.S. legally marketed Electrical Stimulator. i.e. TENS and EMS, as a conductive adhesive interface between the patient's skin and such stimulators. It is for single patient use only. The proposed device mainly consists of substrate and wire. The substrate is available in rectangular shape and round shape.
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    K Number
    K070612
    Device Name
    TOP-RANK ADHESIVE ELECTRODE
    Manufacturer
    TOP-RANK HEALTH CARE EQUIPMENT CO., LTD.
    Date Cleared
    2007-05-07

    (63 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOP-RANK HEALTH CARE EQUIPMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Top-Rank Adhesive Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
    Device Description
    Not Found
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