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

    COMPRES PORTABLE HEAT PADS

    K Number: K821046 · Decision Apr 29, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    374
    Registration Numbers
    374
    Same Product Code
    81
    Applicant Total
    5
    Review Days
    15

    Basic Information

    Device Name
    COMPRES PORTABLE HEAT PADS
    K Number
    K821046
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    S.C. JOHNSON & SON, INC.
    Date Received
    April 14, 1982
    Decision Date
    April 29, 1982
    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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