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510(k) Data Aggregation

    K Number
    K151722
    Device Name
    Slim UP ULTRA
    Manufacturer
    Date Cleared
    2016-03-18

    (267 days)

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

    AIME MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Slim UP® ULTRA is indicated for the use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrode for the purpose of improvement of muscle tone of buttocks muscles.
    Device Description
    Slim UP® ULTRA is a new beauty appliance that works on the principles of Electrostimulation. Slim UP® is used in environments such as Health Spa's and Beauty Salons. Slim UP® ULTRA has following major components: Main power switch, Control panel, Infrared unit, Distribution of electro-stimulation channels. Slim UP® ULTRA electrostimulation section has 8 channels for body electrostimulation with compensated two-phase rectangular waveform, with individual intensity adjustment and 5 different multi-phase treatment programs diversified to meet the needs of the single case. Slim UP® ULTRA infrared section has 6 infrared ray sources housed in a height-adjustable, mobile arm that adapts to any couch, ensuring the ideal working distance is maintained at all times. IR source is used for patient comfort only. It does not have any therapeutic effect. Slim UP® ULTRA is a latest-generation machine occupying only half a square meter. It can be located in any booth, can be adapted to any bed and can be moved anywhere.
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