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    K Number
    K210448
    Device Name
    Adhesive Electrode
    Manufacturer
    Shaoxing Yingtuo Healthcare Co.,Ltd.
    Date Cleared
    2021-08-31

    (196 days)

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

    Shaoxing Yingtuo Healthcare Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
    Device Description
    The adhesive electrode is placed onto human skin and connected with electrical stimulators by lead wires. The electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.
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