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510(k) Data Aggregation

    K Number
    K133108
    Device Name
    FIT BELT
    Date Cleared
    2014-08-05

    (309 days)

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

    HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SM9065 Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. - The big belt is intended for use on the muscles in abdomen. - The small belt is intended for use on the muscles in arms and thighs areas. 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
    SM9065 Fitness Belt is a two channels battery operated muscle stimulation system to achieve the purpose of exercise and relaxation. It is comprised of a main device for signal generation, four belts for fixation, and series electrodes. The big belt is intended for use on muscles in abdomen. The two small belts are intended for use on muscles in arms and thigh areas. Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. 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 and frequency level can be adjusted by user.
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