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

    AIR-FLEX WITH AUTO-DISTRACTION

    K Number: K063034 · Decision Dec 14, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    65
    Applicant Total
    17
    Review Days
    72

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    Basic Information

    Device Name
    AIR-FLEX WITH AUTO-DISTRACTION
    K Number
    K063034
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.5880
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hill Laboratories Co.
    Date Received
    October 3, 2006
    Decision Date
    December 14, 2006
    Product Code
    JFB
    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
    JFB Table, Physical Therapy, Multi Function

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