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510(k) Data Aggregation

    K Number
    K181893
    Device Name
    T-PLUS
    Manufacturer
    Date Cleared
    2019-01-29

    (200 days)

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

    Wintecare SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The T~PLUS is 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, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
    Device Description
    The Wintecare T~PLUS is a device for diathermy / Tecar therapy. It consists of a control unit which generates a radiofrequency current which is delivered to the patient, through two different types of electrodes: stainless steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes are inserted into a smart handle/handpiece, one handpiece for each kind of electrode, and the handpiece is connected to the control unit by means of a 2-metre cable. In resistive mode the system delivers a high-frequency current of 447 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 to pass. The high frequency current is automatically tuned by the equipment according to the patient's impedance. Current returns through the indifferent return electrode. The RF energy generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue. The use of Wintecare Conductive A+ Cream is recommended on the patients' skin prior to each treatment session with the T~PLUS. The cream is offered with the T~PLUS and is part of this 510(k) submission.
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