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510(k) Data Aggregation

    K Number
    K243164
    Device Name
    INDIBA COMPACT devices
    Manufacturer
    INDIBA S. A. U.
    Date Cleared
    2024-11-20

    (51 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    INDIBA S. A. U.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INDIBA COMPACT devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain. muscle spasms and increase in local circulation. The massage electrodes are intended to provide a temporary reduction in the appearance of cellulite.
    Device Description
    The INDIBA COMPACT devices are therapeutic devices for deep, non-invasive diathermy. The device consists of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes: steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes are inserted into a handle/handpiece, one handle for each kind of electrode, and the handle is connected to the console by means of a cable. In resistive mode the system delivers a high- frequency current of 448 kHz directly to the patient's skin surface. In capacitive mode, the electrode coating creates a layer between the electrode and the human tissue, forming a capacitor that allows a high-frequency current at 448 kHz to pass. Current returns through the neutral return electrode. INDIBA Compact devices are provided with an electroconductive media which is applied to the patients' skin prior to each treatment session. The RF energy generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue. In Compact Lite, the temperature on the skin is measured using a separate IR (Infra-red) thermometer and in Compact Plus and Compact Pro temperature is measured through the smart electrodes and smart handle, which inform of the surface skin temperature trough a color scale. There are also other accessories available as massage electrodes with different shapes that can be used to massage the skin during cellulite treatment.
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