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

    MENS FREEDOM MICRO

    K Number: K904430 · Decision May 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    9
    Review Days
    250

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    Basic Information

    Device Name
    MENS FREEDOM MICRO
    K Number
    K904430
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Monad Corp.
    Date Received
    September 5, 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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    Other Clearances by Monad Corp.

    K Number Device Name
    K914441 MENS 2000-D
    K902226 MY-O-MATIC 5000I
    K904235 MENS-O-MATIC 2000
    K904234 MENS-O-MATIC I
    K904258 MICRO DERM
    K904260 MENS-O-MATIC 3000
    K904288 MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS
    K891871 PHASER (SINGLE LINEAR MECHANICAL MASSAGE)