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

    REUSABLE MOIST HEAT PACK

    K Number: K791653 · Decision Sep 7, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    7
    Applicant Total
    3
    Review Days
    24

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    Basic Information

    Device Name
    REUSABLE MOIST HEAT PACK
    K Number
    K791653
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5730
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Tru-Eze Mfg. Co., Inc.
    Date Received
    August 14, 1979
    Decision Date
    September 7, 1979
    Product Code
    IMA
    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
    IMA Pack, Heat, Moist

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