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510(k) Data Aggregation

    K Number
    K963808
    Device Name
    CHOICE POWERED WHEELCHAIR
    Manufacturer
    AMERICAN MEDICAL TECHNOLOGY, INC.
    Date Cleared
    1997-02-12

    (142 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN MEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CHOICE powered wheelchair is intended to provide mobility for a person who, due to medical reasons, the debilitating nature of some illnesses, because of accident, injury and/or subsequent paralysis, is either missing or unable to use the lower extremities. Some, but not all of the specific indications for use of a power wheelchair are: paraplegia, quadriplegia. ALS, muscular dystrophy, muscular sclerosis, lower limb amputation and any one or more of numerous neurological or muscular diseases which render the limbs too weak or unstable for normal use.
    Device Description
    The CHOICE powered wheelchair is manufactured using fabricated steel for the power base and seat assemblies. All components determined to be a permanent part of the structural frame or seating are welded. Any parts which are required to be removable for service or adjustment to perform it's function are attached with locking fasteners. The CHOICE is supplied with two, 12 volt gel cell batteries, either Group 22, Group 24 or Group 27 with a #891 style post, wired in series to provide 24 volts DC [Vortex Batteries, Doraville, GA]. The controller of the device is completely manufactured, tested and certified by Penny & Giles, Dorset, UK, which also contains the software programming and power output to operate the chair's drive motors, as well as interface to various optional features. A joystick, 'sip-n-puff', or alternative control mechanism is used to direct the function of the controller. Two drive motors are located on the power base and attached to a gearbox which provides the appropriate speed control and torque for the chair through a direct drive to the drive wheels. Electrically controlled actuators are used to provide the various movement features of the seating system, including: reduced-shear recline, power elevating leg rests, 'tilt-in-space' and seat elevation. The chair is recharged overnight using a dual-mode, fully automatic battery charger [Lester Electrical, Lincoln, NE Model Number 24EL8, 120V/60Hz] certified for safety and fire resistance in compliance with current ANSI/RESNA standards.
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