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510(k) Data Aggregation

    K Number
    K071573
    Device Name
    RUGALIFT, MODEL# V.2.1
    Manufacturer
    Date Cleared
    2008-12-09

    (550 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    FATROTEK S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RUGALIFT is indicated for cosmetic use.
    Device Description
    Rugalift works by delivering electrical microcurrents to stimulate the skin of the face in a non invasive way. The body of the device includes the electronics for the control of the device, and the power switch for the activation of the device by the user and a detachable applicator with 5 microelectrodes. Rugalift is switched on when the microelectrodes are on the skin and pressing the finger on the power switch. The output of the device increases linearly over the first 10 seconds of stimulation, then it remains constant for 13 seconds and stops. The output cannot be changed by the user. During the treatment, an acoustic signal is activated. The frequency of the acoustic signal increases as the output current increases. When the user removes the device from the face, it automatically resets and turns itself off. Rugalift is powered by a 12V power adapter which is supplied with the device.
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