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

    ORTHOTRAK

    K Number: K890076 · Decision Feb 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    4
    Review Days
    25

    Basic Information

    Device Name
    ORTHOTRAK
    K Number
    K890076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    MOTION ANALYSIS CORP.
    Date Received
    January 9, 1989
    Decision Date
    February 3, 1989
    Product Code
    LXJ
    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
    LXJ Interactive Rehabilitation Exercise Devices

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    Other Clearances by MOTION ANALYSIS CORP.

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