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    K Number
    K112485
    Device Name
    H-WAVE
    Manufacturer
    ELECTRONIC WAVEFORM LAB, INC.
    Date Cleared
    2011-12-06

    (99 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTRONIC WAVEFORM LAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The H-Wave® H4 is indicated for the treatment of chronic pain, acute pain, postsurgical pain, and temporary pain.
    Device Description
    The H-Wave® model H4 consists of a portable battery operated electrical stimulation device with two channels, two sets of lead wires, three packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons to select the desired frequency and a dial to control the intensity of the signal. The stimulator also is supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display. The device creates therapeutic stimulation at frequencies of 1-70 Hz depending on the physician instructions and patient settings.
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