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

    NEURODYN MULTIWAVE, AUSSIE SPORT

    K Number: K131629 · Decision Nov 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    6
    Review Days
    175

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    Basic Information

    Device Name
    NEURODYN MULTIWAVE, AUSSIE SPORT
    K Number
    K131629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ibramed Equipamentos Medicos
    Date Received
    June 4, 2013
    Decision Date
    November 26, 2013
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

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