BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS

    K Number: K904288 · Decision May 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    9
    Review Days
    236

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    Basic Information

    Device Name
    MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS
    K Number
    K904288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Monad Corp.
    Date Received
    September 19, 1990
    Decision Date
    May 13, 1991
    Product Code
    GZJ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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    K904258 MICRO DERM
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