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

    KNEE BRACE/STABILIZER

    K Number: K802673 · Decision Nov 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    442
    Registration Numbers
    442
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    16

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    Basic Information

    Device Name
    KNEE BRACE/STABILIZER
    K Number
    K802673
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Omni Scientific, Inc.
    Date Received
    October 27, 1980
    Decision Date
    November 12, 1980
    Product Code
    ITQ
    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
    ITQ Joint, Knee, External Brace

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