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510(k) Data Aggregation

    K Number
    K122414
    Device Name
    AB COMMAND DUAL CHANNEL FITNESS BELT
    Manufacturer
    LETO ENTERPRISES INCORPORATION
    Date Cleared
    2012-12-21

    (135 days)

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

    LETO ENTERPRISES INCORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AB COMMAND Dual Channel Fitness Belt is intended for use by healthy persons to apply trans-coetancous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen. The AB COMMAND Dual Channel Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal muscles. Contraindicated use on injured or otherwise impaired muscles. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
    Device Description
    AB COMMAND Dual Channel Fitness Belt is a two channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module for signal generation, a belt for fixation, and four electrodes for signal connection to skin. The built-in electrodes are located on the inner surface of the belts. Power is derived from 2 batteries located in a compartment protected by a removable battery cover for the Fitness Belt. There is no current passed from side to side. The user cannot access the wiring or connectors within the belt. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level can be adjustable by user.
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    K Number
    K102295
    Device Name
    X2ABS DUAL CHANNEL FITNESS BELT
    Manufacturer
    LETO ENTERPRISES INCORPORATION
    Date Cleared
    2011-02-18

    (189 days)

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

    LETO ENTERPRISES INCORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X2ABS Dual Channel Fitness Belt is intended for use by healthy persons to apply trans-coetaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen. The X2ABS Dual Channel Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal muscles. Contraindicated use on injured or otherwise impaired muscles. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
    Device Description
    X2ABS Dual Channel Fitness Belt is a two channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module for signal generation, a belt for fixation, and four electrodes for signal connection to skin. The built-in electrodes are located on the inner surface of the belts. Power is derived from 2 batteries located in a compartment protected by a removable battery cover for the Fitness Belt. There is no current passed from side to side. The user cannot access the wiring or connectors within the belt. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level can be adjustable by user.
    Ask a Question

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