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510(k) Data Aggregation

    K Number
    K152815
    Device Name
    Mailuokang Self-adhesive Electrode
    Manufacturer
    SHENZHEN MAILUOKANG TECHNOLOGY CO., LTD.
    Date Cleared
    2016-03-08

    (162 days)

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

    SHENZHEN MAILUOKANG TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mailuokang Self-adhesive Electrode is intended for use as reusable, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Example electrical stimulation devices for current applications of the electrodes, but are not limited to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.
    Device Description
    Mailuokang Self-adhesive Electrode is used as a reusable and re-positionable transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.
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