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

    PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER

    K Number: K031897 · Decision Sep 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    10
    Review Days
    96

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    Basic Information

    Device Name
    PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
    K Number
    K031897
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Imc-Heart Way LLC
    Date Received
    June 19, 2003
    Decision Date
    September 23, 2003
    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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