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510(k) Data Aggregation

    K Number
    K133033
    Device Name
    HIDREX PSP1000
    Manufacturer
    HIDREX GMBH
    Date Cleared
    2015-04-08

    (559 days)

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

    HIDREX GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Tap-Water-Iontophoresis device is intended to treat hyperhidrosis (pathological sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered use and may have dangerous consequences.
    Device Description
    HIDREX iontophoresis devices are primarily intended for treating hyperhidrosis (excessive sweating) of hands and/or feet. Provided the optional axillary applicators are utilized, the system can also be used for treating axillary hyperhidrosis. The system consists of a control unit, power supply/safety wall adapter, and application accessories (treatment cover towel, treatment electrode, axillary sponge cushions). The control unit includes connection-jackets for accessories, control-buttons to choose the therapy-mode, a main display, and LED indicators. The device offers both DC and pulsed current output with adjustable pulse-width.
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