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510(k) Data Aggregation

    K Number
    K021794
    Device Name
    TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING)
    Manufacturer
    TATUNG CO.
    Date Cleared
    2003-01-13

    (227 days)

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

    TATUNG CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TATUNG TMD-26AX SERIES TENS is intended for symptomatic relief and management of chronic intractable pain.
    Device Description
    TATUNG TMD-26AX SERIES TENS Transcuntaneus Electrical Nerve Stimulation System, designed for symptomatic relief and management of chronic intractable pain. It provides a combination of four stimulant modes and good for muscular pain. The device has five preprogrammed function mode, and adjustable output intensity and stimulating rate. With large LCD panel. It is powered by three(3) AAA 1.5V Battery. TATUNG TMD-26AX SERIES TENS requires the use of a set of leadwire and one pair of cutaneous stimulation electrodes.
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