BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IMNI HOT PACKS

    K Number: K955788 · Decision Sep 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    377
    Registration Numbers
    377
    Same Product Code
    81
    Applicant Total
    5
    Review Days
    257

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    Basic Information

    Device Name
    IMNI HOT PACKS
    K Number
    K955788
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Omni Therm, Inc.
    Date Received
    December 22, 1995
    Decision Date
    September 4, 1996
    Product Code
    IMD
    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
    IMD Pack, Hot Or Cold, Disposable

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    Other Clearances by Omni Therm, Inc.

    K Number Device Name
    K961176 OMNI COLD GEL PACKS
    K954877 OMNI COLD GEL PACKS
    K936084 OMNI WARM GEL PACKS
    K864853 OMNI THERM TEMPERATURE MONITOR