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    K Number
    K030140
    Device Name
    DUOMED, SERIES 500, (MODELS ID 500, FL 500)
    Manufacturer
    DUOMED INC.
    Date Cleared
    2003-03-18

    (63 days)

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

    DUOMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for the symptomatic relief and management of chronic (long term) intractable pain ind/or as an adjunct treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    The DuoMed™ Series 500 is a non-invasive nerve stimulation therapy device, indicated for use in treatment of symptomatic relief of and management of long-term intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain. It has an adjustable pulse amplitude, pulse rate, and pulse width, with an automatic modulation mode for the pulse width. It can be used in "normal" modes,"burst" mode or in "modulation" mode following the directions of the prescribing physician. Like the Graham-Field (and several other) devices it operates with a 9 V alkaline or nickel-cadmium rechargeable battery.
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