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

    CYBEX BACK TESTING AND REHABILITATION SYSTEM

    K Number: K881681 · Decision Apr 25, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    60
    Applicant Total
    9
    Review Days
    736

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    Basic Information

    Device Name
    CYBEX BACK TESTING AND REHABILITATION SYSTEM
    K Number
    K881681
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1925
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Cybex
    Date Received
    April 19, 1988
    Decision Date
    April 25, 1990
    Product Code
    IKK
    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
    IKK System, Isokinetic Testing And Evaluation

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