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510(k) Data Aggregation

    K Number
    K202653
    Device Name
    Gymform Total ABS
    Date Cleared
    2021-01-15

    (123 days)

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

    Well Brain International Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gymform® TOTAL ABS (Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.
    Device Description
    The Gymform® TOTAL ABS( Model: WB-245) consists of a control unit, large belt, small belt and electrode pads. The control unit enclosed in ABS plastic case. The device is design based on Microcurrent technology (Electro Muscle Stimulation-EMS) which uses a gentle current to condition, tone and strengthen muscles. The Gymform® TOTAL ABS( Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The TOTAL ABS may be considered a technique or method for muscle training. It is a battery operated muscle stimulation system specifically designed to training muscles. The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately. 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. There are 6 modes for output stimulation, and for each mode, there are 10 levels of output intensity can be choose. Default time is 10minutes for output stimulation. Power is derived from 3 pieces of AAA batteries located in a compartment protected by a removable battery cover for the Fitness Belt.
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