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510(k) Data Aggregation

    K Number
    K122393
    Device Name
    TG-BODY MI&BODY S-TRAINER
    Date Cleared
    2013-12-10

    (490 days)

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

    MIGA MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TG-BODY, MI&Body, S-Trainer are intended to stimulate healthy muscles in order to improve or facilitate muscle performance and not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
    Device Description
    The MIGA Co.,Ltd OTC EMS System . model TG-Body. S-Trainer and Mi&Body are intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance; it is not intended as a therapy for any medical condition. Basically the model TG-body, powered by 4.8V, S-Trainer, powered by 3.6V and Mi&Body, powered by 3.7V are muscle stimulation devices and identical to the predicate device -K011880 (Compex Sport) with the following features: It is a portable, battery operated neuromuscular electronic stimulation system. It contains 6 programs as similar to the predicate device; the output waveform is selectable pre-programming change among P1-P6 (in case of TG-body 10) The output strength is adjustable at 0-100mA via regulated voltage, with variable set time 5-60 minutes counting from starting session. The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication.
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