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

    MODEL 1100 COLD THERAPY DEVICE

    K Number: K955057 · Decision Mar 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    92
    Applicant Total
    15
    Review Days
    123

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    Basic Information

    Device Name
    MODEL 1100 COLD THERAPY DEVICE
    K Number
    K955057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Smith and Nephew Donjoy, Inc.
    Date Received
    November 6, 1995
    Decision Date
    March 8, 1996
    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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