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510(k) Data Aggregation

    K Number
    K192749
    Device Name
    Dermadry
    Manufacturer
    Dermadry Laboratories inc.
    Date Cleared
    2020-02-10

    (133 days)

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

    Dermadry Laboratories inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermadry is a Tap Water Iontophoresis device. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands, feet and underarms. Using the device in any other way than its intended purpose may be dangerous.
    Device Description
    The Dermadry is a tap water Iontophoresis device intended to treat hyperhidrosis of the hands, feet and underarms. It achieves its action by producing a given low level direct current (DC) level between each of the two applicable members being treated (i.e. the two feet, or the two hands, or the two underarms) for a given amount of time. The current is controlled and transmitted by a controller between two electrodes in separate water basins into which each of the hands or feet are placed, or via two electrodes within water soaked spongeous pockets that are placed in each of the underarms. It is for home use by a single patient (single patient). It is for use by prescription under the direction of a physician or clinician, and is intended for adult patients.
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