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

    MODEL 1100 COLD THERAPY DEVICE

    K Number: K970533 · Decision Apr 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    92
    Applicant Total
    529
    Review Days
    62

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    Basic Information

    Device Name
    MODEL 1100 COLD THERAPY DEVICE
    K Number
    K970533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew, Inc.
    Date Received
    February 12, 1997
    Decision Date
    April 15, 1997
    Product Code
    ILO
    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
    ILO Pack, Hot Or Cold, Water Circulating

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