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510(k) Data Aggregation

    K Number
    K031995
    Device Name
    COMPREHENSIVE NEUROMUSCULAR PROFILER
    Manufacturer
    MEDICAL TECHNOLOGIES UNLIMITED, INC.
    Date Cleared
    2004-01-07

    (194 days)

    Product Code
    IKN
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL TECHNOLOGIES UNLIMITED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surface electromyography with range of motion tracking, functional capacity and grip strength measuring.
    Device Description
    The Comprehensive Neuromuscular Profiler is a muscle and range of motion monitoring system that is portable, stand-alone and in a convenient package suitable for use in a medical environment. The system consists of a number of sensors to be connected to various parts of the human body which will be fed into a customized enclosure containing all connectors and mediums for conditioning, acquiring and transferring the sensor data. The conditioned data will then be sent to the notebook computer (PC) that is connected to the enclosure. The system will be capable of monitoring and recording data from electromyography (EMG) sensors connected to various muscle groups in the human body. During the acquisition of EMG signals, the system will simultaneously acquire motion of the body and/or muscle strength.
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