BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇿 Czechia

    Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE

    K Number: K170835 · Decision Jun 15, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    452

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    Basic Information

    Device Name
    Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
    K Number
    K170835
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hightech Development
    Date Received
    March 20, 2017
    Decision Date
    June 15, 2018
    Product Code
    EGJ
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EGJ Device, Iontophoresis, Other Uses

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