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

    MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33

    K Number: K020002 · Decision Mar 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    4
    Review Days
    78

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    Basic Information

    Device Name
    MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33
    K Number
    K020002
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Transworld Mobility Distribution, LLC
    Date Received
    January 2, 2002
    Decision Date
    March 21, 2002
    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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    Other Clearances by Transworld Mobility Distribution, LLC

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    K020001 PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3
    K011745 HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
    K011744 HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR