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510(k) Data Aggregation

    K Number
    K111476
    Device Name
    CONTOUR TECHNOLOGY MUSCLE STIMULATOR
    Manufacturer
    CONTOUR TECHNOLOGY
    Date Cleared
    2012-05-23

    (362 days)

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

    CONTOUR TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training. The Contour Technology Muscle Stimulator Ab Belt accessory is intended for use on abdominal muscles only for strengthening and toning of abdominal muscles. The Contour Technology Muscle Stimulator BackPad accessory is intended for use on the lower back muscles only.
    Device Description
    The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training for improvement of muscle tone, for the strengthening of the following muscles: upper back, lower/mid back, lower back, biceps, triceps, forearm-flexor, forearm-extensor, deltoids, abdominal, gluteus, hamstrings, quadriceps, and calves for the development of firmer muscles. The electrical stimulation is delivered to the muscles through two channels. The output signal is monophasic, rectangular and based on a regulated voltage technology. The parameters (pulse rate, pulse duration, stimulation time, rest time) are optimized for each program. The power is supplied by 4 AAA batteries. Pulses, transmitted by the Contour Technology Muscle Stimulator are sent to Gel Pad electrodes placed over the muscle region. The signal reaches out to the motor neuron that innervates the muscle fiber resulting in contraction of the muscle. The energy is delivered through 2-3 pairs of gel pads. Optional accessories are available to allow for hands free operation of the device when placed on the abdomen or back.
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