BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ZEOBI

    K Number: K121338 · Decision Jul 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    85

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    Basic Information

    Device Name
    ZEOBI
    K Number
    K121338
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5290
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ivivi Health Science, LLC
    Date Received
    May 3, 2012
    Decision Date
    July 27, 2012
    Product Code
    ILX
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

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