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510(k) Data Aggregation

    K Number
    K183371
    Device Name
    Deka Tiac 1
    Manufacturer
    El..En. Electroic Engineering SpA
    Date Cleared
    2019-12-03

    (362 days)

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

    El..En. Electroic Engineering SpA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DEKA TIAC1 RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The DEKA TIAC 1 massage device is intended to provide a temporary reduction in the appearance of cellulite.
    Device Description
    The DEKA TIAC 1 is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite. The DEKA TIAC 1 consists of the following main components: - microprocessor-driven control unit - high-frequency electromagnetic energy generator - user interface with 10.4" color touch screen - 2 RF handpieces for application of radiofrequency - 2 integrated massaging balls handpieces Contact quality monitoring system is present for monitoring of the contact quality under the RF handpiece electrodes. The electrical specifications are 100-240Vac, 50/60Hz, 1500VA.
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