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510(k) Data Aggregation

    K Number
    K183103
    Device Name
    EMS Belt (Model MC0485)
    Date Cleared
    2019-09-18

    (315 days)

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

    **Dongguan Yingfeng Metal **& Plastic Products Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    MC0485 EMS Belt is a one 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 electrode pads for signal connection to skin. The built-in electrode pads are located on the inner surface of the belt. Power is derived from 3 batteries located in a compartment protected by a removable battery cover for the EMS 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 area through the electrode pads placed on the skin. The parameters of the EMS Belt are controlled by the buttons on the controller and are displayed by the LCD on the controller. Its intensity level can be adjustable by user.
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