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510(k) Data Aggregation

    K Number
    K083016
    Device Name
    ACTHYDERM
    Date Cleared
    2009-06-16

    (250 days)

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

    MICROLAB AMERICAS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ActhyDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
    Device Description
    ActhyDerm is a device that is a microprocessor controlled iontophoresis drug delivery system. The microprocessor bas four pre-set programs for penetration of the 1) epidermis, 2) dermis, 3) adipose, 4) muscle. It has a dispersive electrode and roller electrodes. An FDA approved conductive grounding pad is also required prior to its use. Introducing ions can be accomplished with ActhyDerm's Dispensing Electrode and roller using methods described with operator's manual: roller conducts current to the skin via the product to be delivered. The product has a positive charge, the current coming into the roller has a positive charge and when they meet the current are diffused into the skin are diffused into the skin.
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