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510(k) Data Aggregation

    K Number
    K110057
    Device Name
    MINI MASSEUSE
    Date Cleared
    2011-10-28

    (291 days)

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

    MJ SPECIALTY RETAIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Mini, Model EC12-01 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Mini, Model EC12-01 is not intended to be used as a therapy for any medical condition. None of the Mini programs are designed for injured or ailing muscles and their use on such muscles is contraindicated. Mini, Model EC12-01 is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation(EMS) through skin contact electrodes. Indications for use are as follows: Mini is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Mini is not intended to as a therapy for any medical condition. Please read the indications, precautions and warnings carefully to determine whether any of them apply to you. Mini stimulates action potentials in the motor nerves supplying muscle. Different patterns of muscle activity can be imposed on the target muscle, depending on the timing and intensity of the stimulation signal. Mini contains programs for exercise warm-up, muscle performance improvement and exercise recovery.
    Device Description
    The Mini is a powered muscle stimulator for muscle conditioning. It is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatique resistance. Unlike the classified powered muscle stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes. The Mini is a 9 volt battery powered hand-held device, with detachable electrodes. The electrodes are placed over the muscles which are to be stimulated. The muscles are excited by electric pulses which are created by an electronic circuit. This circuit is software driven, to the user can adjust the stimulation. Mini is pre-programmed with 6 stimulation programs. Programs duration varies depending on the selected mode, which can be reduced by user inputs.
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