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510(k) Data Aggregation

    K Number
    K170835
    Device Name
    Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
    Manufacturer
    Hightech Development
    Date Cleared
    2018-06-15

    (452 days)

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

    Hightech Development

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electro Antiperspirant, Electro Antiperspirant Sensitive, and the Electro Antiperspirant ELITE are tap water iontophoresis devices intended to treat hyperhidrosis (excessive sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered un-intended use and may have dangerous consequences.
    Device Description
    Not Found
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