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

    VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)

    K Number: K053503 · Decision Dec 28, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    70
    Applicant Total
    1
    Review Days
    12

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    Basic Information

    Device Name
    VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
    K Number
    K053503
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vax-D Medical Technologies USA, L.C.
    Date Received
    December 16, 2005
    Decision Date
    December 28, 2005
    Product Code
    ITH
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    ITH Equipment, Traction, Powered

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