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510(k) Data Aggregation

    K Number
    K073008
    Device Name
    KFH ENERGY, MODEL: E1
    Date Cleared
    2008-03-11

    (139 days)

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

    KINGFISHER HEALTHCARE NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KFH Energy device is indicated for the symptomatic relief of: - Chronic Intractable Pain - Post-Traumatic Pain - Post-Surgical Pain
    Device Description
    The Kingfisher Healthcare NV KFH Energy model E1 is built in an ABS casing with controls and indicator integrated into a touch-sensitive opaque glass front panel, and designed to be comfortably held in the hand. The approximate dimensions of the unit are 190 x 80 x 30 mm and complete with batteries the unit weighs approximately 350 g (including batteries). The device is designed to deliver electric current in the range 300 to 600 microamperes at 100 Hz frequency to the body from four "AA" sized batteries (contained internally), for a predctermined time (30 or 60 minutes), through four adhesive skin electrodes (already found substantially equivalent through the 510(k) process). The output waveform is monophasic, rectangular with decay.
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