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510(k) Data Aggregation

    K Number
    K121338
    Device Name
    ZEOBI
    Manufacturer
    IVIVI HEALTH SCIENCE, LLC
    Date Cleared
    2012-07-27

    (85 days)

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

    IVIVI HEALTH SCIENCE, LLC

    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
    The Zeobi is a portable battery powered non-invasive therapy device which applies 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 Zeobi was designed to deposit mean radio frequency energy in tissue which is equivalent to that of the Torino II. The Zeobi delivers the RF signal to the tissue target via inductive coupling with an applicator coil. The device is portable and treatment can occur directly through dressings, clothing, casts, compression garments or supports.
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