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510(k) Data Aggregation

    K Number
    K070541
    Device Name
    IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II
    Manufacturer
    IVIVI TECHNOLOGIES, INC.
    Date Cleared
    2008-12-11

    (654 days)

    Product Code
    ILX
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVIVI TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
    Device Description
    SofPulse (912-M10, Roma3 and Torino II) devices are shortwave diathermy medical devices which apply to the body electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The SofPulse models were designed to deposit mean radio frequency energy in tissue which is equivalent to that of the predicate MRT device. All of the SofPulse options deliver the RF signal to the tissue farget via inductive coupling with an applicator coil. SofPulse devices are portable and treatment can occur directly through dressings, clothing, casts, compression garments or supports.
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