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510(k) Data Aggregation

    K Number
    K012492
    Device Name
    KADANCE 2000
    Manufacturer
    KADA RESEARCH, INC.
    Date Cleared
    2001-11-02

    (91 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Applicant Name (Manufacturer) :

    KADA RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Any situation where the hand grip or pinch strength would be a valuable piece of data in the evaluation of a person who has sustained an injury or suffers a disease of his/her hand(s). To measure grip or pinch strength in an injured and uninjured hand. To conduct pre-employment screening for physically demanding job activities. To establish an industrial strength testing program in general, and to match the strength of workers to the strength demands of specific job duties in the workplace.
    Device Description
    The KaDance 2000 system is designed to aid in the identification of fine motor performance issues, (median nerve entrapment), which may be present in either or both hands of a human. The system is non-invasive. This is accomplished by measuring how the thumb (digit 1), index finger (digit 2) and little finger (digit 5) maintain a grip throughout several repetitive exercisers. The applied forces exerted by the digits measured as a function of time. Measurements may be made as rapidly as once every 2 ms for all three digits simultaneously. The system consists of 1) hand sensor, 2) a data control module and laptop computer, 3) KaDaLink™ computer with KaDance 2000 software running. Data is displayed as force over time.
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