Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K943535
    Device Name
    MODEL ME 300 MUSCLE TESTER
    Date Cleared
    1997-06-25

    (1070 days)

    Product Code
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGULATORY STRATEGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Model ME300 Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle reeducation and relaxation training.
    Device Description
    The ME300 is a portable, battery powered EMG recorder. The ME300 is an electronic device used to gather and display electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training. The signals are received via conductive adhesive skin electrodes and may be displayed or stored for display at a later time. Signals may be gathered from two channels. Data downloading or transfer is via a standard fiber optic cable to a PC. The product does not relay any electrical or stimulatory signals to the body. It is only a signal recorder with display capabilities.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1