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

    2K-QDA MOTION/GAIT ANALYSIS SYSTEM

    K Number: K880631 · Decision Apr 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    65

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    Basic Information

    Device Name
    2K-QDA MOTION/GAIT ANALYSIS SYSTEM
    K Number
    K880631
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Human Performance Technologies, Inc.
    Date Received
    February 16, 1988
    Decision Date
    April 21, 1988
    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 Human Performance Technologies, Inc.

    K Number Device Name
    K882139 2P-QDA FOOT PRESSURE SYSTEMS REAL TIME