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    K Number
    K033193
    Device Name
    SONOSENS
    Manufacturer
    FRIENDLY SENSORS AG
    Date Cleared
    2004-01-23

    (113 days)

    Product Code
    NKI
    Regulation Number
    888.1500
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    Product Code :

    NKI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Continuous real-time measurement of range of motion.
    Device Description
    The sonoSens® is a non-invasive device indicated for use in real-time measurement of range of motion. The measuring device consists of a monitor central processing unit (CPU), the power supply, and an infrared interface for data transfer. The device is connected to eight sensors via cables. Each sensor is directly attached to the skin with an adhesive pad.
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