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510(k) Data Aggregation

    K Number
    K091875
    Device Name
    E-PULSE
    Manufacturer
    MEDEVICE CORPORATION
    Date Cleared
    2009-12-07

    (167 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDEVICE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    E-pulse is an electro-acupuncture device for use in the practice of Acupuncture by qualified practitioners of acupuncture as determined by the state.
    Device Description
    Miniaturized, battery powered unit designed to administer auricular point stimulation treatment over a 96 hour period. The device is on for 3 hours, then off for 3 hours. It has a pre-programmed micro-processor as to frequency, pulse and duration for the stimulation of the auricular acupuncture points. The device itself is applied on the neck, below the ear with the integrated selfadhesive electrode patch. The voltage source is from the three batteries 1.4 volts (each). The device has different frequency modes and waveform modes. The wires from the device are connected to the acupuncture needles simply by positioning and snapping a plastic ring over the semi-permanent acupuncture needles.
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