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510(k) Data Aggregation

    K Number
    K030800
    Device Name
    ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES
    Manufacturer
    ELETROMED, INC.
    Date Cleared
    2003-06-11

    (90 days)

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

    ELETROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electromed Reusable Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electromed Reusable Electrodes are designed and intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) of PGF (Pulsed Galvanic Stimulation).
    Device Description
    Electrodes, cutaneous
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