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

    THERMO TRIM

    K Number: K852637 · Decision Nov 20, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    259
    Registration Numbers
    259
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    153

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    Basic Information

    Device Name
    THERMO TRIM
    K Number
    K852637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5740
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Suntec Health & Fitness Group, Inc.
    Date Received
    June 20, 1985
    Decision Date
    November 20, 1985
    Product Code
    IRT
    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
    IRT Pad, Heating, Powered

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