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

    REGAL MOTORIZIED 3 WHEELED VEHICLE

    K Number: K921647 · Decision May 4, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    12
    Review Days
    28

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    Basic Information

    Device Name
    REGAL MOTORIZIED 3 WHEELED VEHICLE
    K Number
    K921647
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bruno Independent Living Aids, Inc.
    Date Received
    April 6, 1992
    Decision Date
    May 4, 1992
    Product Code
    INI
    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
    INI Vehicle, Motorized 3-Wheeled

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