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510(k) Data Aggregation

    K Number
    K994083
    Device Name
    STANNAH POWER CHAIR, MODEL 201
    Date Cleared
    2001-04-04

    (488 days)

    Product Code
    Regulation Number
    890.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    STANNAH POWER CHAIRS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Stannah power Chair is intended as a device to provide personal transport for a person with walking difficulties. It is specifically designed to for indoor use in a domestic type environment.
    Device Description
    The Power Chair is a powered wheelchair based around a high quality office chair. Attached to the chair is a proprietary controller unit, which can be mounted on either side of the seat. The motion is operated by the user hand via a joystick. The attachment method allows the controller to be positioned further forward or backwards relative to the chair for comfort and convenience of the user. The chair is attached to a base assembly containing the drive motors, drive wheels, castor wheels and batteries, by a Gas Strut (anti-rotate) which enables the chair to be raised or lowered within set limits. Operation may be either manual, using a hand lever, or with a powered version option, via a separate control on the controller unit. The powered height adjustment can not be made while the power chair is driving in any direction. The Base is a profiled and of folded sheet steel fabrication, to which the two drive motor/gearboxes, two drive wheels, five castor wheels and a footrest assembly are mounted directly.
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