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510(k) Data Aggregation

    K Number
    K191181
    Device Name
    NXPRO Neuromuscular Electrical Stimulation Device
    Date Cleared
    2019-10-11

    (162 days)

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

    NeuX Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Neux NXPRO Neuromuscular Electrical Stimulation Device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The Neux NXPRO is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The NeuX NXPRO is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated. The NeuX NXPRO's electrical impulses allow triggering action potential on motor nerves (excitations). These excitations of motor neurons are transmitted to 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 the NeuX NXPRPO can impose on the stimulated muscles are able to improve or facilitate muscle performance. The NeuX NXPRO is considered a technique of muscle training.
    Device Description
    The NeuX NXPRO Neuromuscular Electrical Stimulation Device generates electrical impulses the result in a triggering action potential on motor neurons of motor nerves (excitations). These excitations of motor neurons are transmitted to the muscle fibers through the system electrodes where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses: (a) pulse frequency; (b) duration of muscle contraction; (c) duration of rest; and (d) total session duration; different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the NXPRO can impose on the stimulated muscles are able to improve or facilitate muscle performance. Note: the application of the NXPRO is considered a technique of muscle training.
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