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

    BODY WARMER

    K Number: K780426 · Decision Apr 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    377
    Registration Numbers
    377
    Same Product Code
    81
    Applicant Total
    1
    Review Days
    41

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    Basic Information

    Device Name
    BODY WARMER
    K Number
    K780426
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Q-Matic Corp.
    Date Received
    March 17, 1978
    Decision Date
    April 27, 1978
    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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