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510(k) Data Aggregation

    K Number
    K110048
    Device Name
    CERSR ELECTROMYOGRAPHY SYSTEM
    Manufacturer
    SPINEMATRIX, INC.
    Date Cleared
    2011-01-26

    (20 days)

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

    SPINEMATRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CERSR® Electromyography System is intended to be used by properly trained technicians and/or physicians in clinical settings. The CERSR® Electromyography System is indicated for use to monitor and display the bioelectric signals produced by muscles to aid in the diagnosis and prognosis of muscular disease or dysfunction.
    Device Description
    The CERSR® is an Electromyography System. The CERSR® Electromyography System is specifically designed for a real-time recording of muscle electrophysiology. The CERSR® Electromyography System allows for a real-time recording from multiple locations by applying an array of surface electrodes over the anatomical region of interest. Each electrode is connected to its own channel with a preamplifier, amplifier, buffers and filters. The CERSR® Electromyography System produces a user display of the myoelectric signals. These recordings may be viewed in one of three standard formats, as a typical waveform, RMS display or a frequency spectral analysis plot. The system consists of the following components: 1) a system cart comprised of a CPU: 2) a mouse and keyboard; 3) monitor; 4) printer; 5) two buffer amplifiers; 6) power distribution box. which contains a filter buffer box; 7) isolation transformer; 8) two power supplies; and 9) a static ground system. The CERSR® system contains software and includes a disposable electrode array. Additional accessories provided with the system include a goniometer, a flexible transparent ruler, and two 3-pound weights.
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