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

    GAZELLE WHEELCHAIR

    K Number: K020536 · Decision Mar 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    445
    Applicant Total
    1
    Review Days
    24

    Basic Information

    Device Name
    GAZELLE WHEELCHAIR
    K Number
    K020536
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ALUM CREEK WHEELCHAIR CO., INC.
    Date Received
    February 19, 2002
    Decision Date
    March 15, 2002
    Product Code
    IOR
    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
    IOR Wheelchair, Mechanical

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