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510(k) Data Aggregation

    K Number
    K180773
    Device Name
    Reusable and Self-Adhesive Electrodes
    Date Cleared
    2018-05-22

    (60 days)

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

    Shaoxing DongZhi Electrical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is an adhesive electrode which is intended for use as the re-usable, conductive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with legally marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
    Device Description
    The Reusable and Self-Adhesive Electrodes are made of conductive hydrogel, fabric cloth and carbon film. They work when sticking to human skin and connecting with electrical stimulators by lead wires. During the treatment, electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.
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