Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K011880
    Device Name
    COMPEX SPORT
    Manufacturer
    COMPEX S.A.
    Date Cleared
    2002-04-17

    (306 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPEX S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "Compex® Sport" is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. "Compex® Sport" is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the "Compex® Sport" training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The "Compex® Sport" electrical impulses allow triggering action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that "Compex® Sport" can impose on the stimulated muscles are able to improve or facilitate muscle performance. "Compex® Sport" may therefore be considered a technique of muscle training.
    Device Description
    "Compex® Sport" is a portable, battery operated neuromuscular electrical stimulator. Equipped with four channels, it works with a rechargeable battery and offers an easy-to-read LCD display.
    Ask a Question

    Page 1 of 1