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    K Number
    K031546
    Device Name
    RAINBOW GT-4A PAIN RELIEF MACHINE
    Manufacturer
    SINO-US INFORMATION, INC
    Date Cleared
    2003-11-13

    (181 days)

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

    SINO-US INFORMATION, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rainbow® GT-4A machine is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
    Device Description
    The Rainbow® GT-4A is a tetrad channel traditional TENS device. It is powered by an AC adaptor. All operation modes produce the GT Bi-phasic waveform. The GT-4A requires the use of a set of lead wires and a pair of electrodes for each channel.
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