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510(k) Data Aggregation

    K Number
    K152420
    Device Name
    AK Body Toning Device
    Manufacturer
    AK BEAUTY ENTERPRISES, LLC
    Date Cleared
    2016-12-01

    (463 days)

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

    AK BEAUTY ENTERPRISES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AK Body Toning Device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin-contact electrodes in order to improve or facilitate muscle performance.
    Device Description
    The AK Body Toning Device is a battery-operated, hand-held, single-program, muscle stimulation system to tone healthy muscles of the abdomen, thighs, and buttock. The device is self- contained with three rows of axels under a rounded unit with a handle that is shaped to allow a comfortable hand-grip for the user. Each axel has three knobbed wheels. The two sets of stainless on the ends are the powered electrodes and the middle set of plastic wheels allows for easier movement across the skin. The device produces transcutaneous electrical muscle stimulation through the powered electrodes that are approximately four inches apart. An on-off switch applies the power and an adjustable knob sets the intensity of the treatment. An electroconductive gel is applied to the skin in the area to be treated and the device is rolled across the treatment area. The knob is adjusted until the treatment is effective and may be increased after initial use.
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