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510(k) Data Aggregation

    K Number
    K061522
    Device Name
    TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM
    Manufacturer
    ACTIVA TEK INC
    Date Cleared
    2006-08-01

    (60 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACTIVA TEK INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trivarion Buffered Iontophoresis Electrode System is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.
    Device Description
    The Trivarion Buffered Iontophoresis Electrode System consists of a disposable, single-use iontophoresis electrode and return electrode. A packaged 70% isopropyl alcohol patch (Becton Dickinson, Franklin Lakes, NJ 07417) is also included. The Trivarion lontophoresis Electrode System does not include the iontophoresis electrical generator or the electrical lead wires. Commercially available, FDA approved microprocessor controlled constant current generators such as the lomed phoresor or EMPI Dupel may be connected to the Trivarion electrodes. The Trivarion Iontophoresis Electrode is buffered by the use of silver-silver chloride for administered doses in the range of 40-80 mAmp*min for both polarities, negative and positive.
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