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510(k) Data Aggregation

    K Number
    K033263
    Device Name
    K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT
    Manufacturer
    Date Cleared
    2003-10-31

    (22 days)

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

    TRACK CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The K-Tech 2 is appropriate for use by individuals that use a power wheelchair for mobility and require positioning changes without the aid of an attendant. These positioning changes are needed for, but not limited to: - Comfort for increased sitting tolerance . - Positioning to increase upper body stability . - Pressure relief or reduction to shift the end user's body weight from the buttocks to the back . Track Corporation makes no claims as to the therapeutic effectiveness of this device. our only claims relate to the ability of the device to provide safe and reliable change in positioning capability on the equipment that it is installed.
    Device Description
    The Track Corporation K-Tech Power Tilt Seating System is an aftermarket, center of gravity design power tilt in space system for power wheelchairs. The K-Tech 2 is designed to be able to be installed in the field by qualified dealerships on to most commercially available power wheelchairs appropriate for power seating accommodation. The standard system configuration consists of two sets of steel tracks, an inner and outer set. This track configuration has been used in the automotive industry very successfully for many years, under more rigorous conditions than wheelchairs experience. The outer tracks of the K-Tech 2 are attached to the power wheelchair via mounting hardware that is designed to interface to each specific power chair. The outside tracks also provide the quide tracks for the inside tracks to tilt and slide forward, creating the center of gravity movement. The aluminum seat pan and the inside tracks support the back support uprights. The K-Tech 2 utilizes an automotive seat adjuster motor manufactured by Fasco and has a maximum load capacity of 500 pounds. The Fasco motor has an integrated overload protection to protect the motor from current overload and over use by the end user. The tilt drive assembly found integrated into the back end of the inner tracks follows a steel leadscrew attached inside of each of the outer tracks. This creates a dual screw drive which is much more efficient and does not put the users weight directly on the tilt adjuster, unlike on the actuators that are found on the predicate device(s). This is a significant improvement in durability and safety in power wheelchair seating. If the motor should ever fail, the tilt drive assembly will not change its relationship to the leadscrew. The end user is protected from the system either falling backward or free falling back down to the neutral seated position due to motor failure. An additional benefit of using the tilt drive assembly and ball screw is the tilting of the system is achieved by the movement of the screw quide on the ball screw. This allows the device to tilt and slide forward without exerting great stress and opposing forces on the frame, which exist on the predicate devices and all other available tilt power seating systems. Over time, these opposing forces cause undue strain on the frame, leading to possible serious failure. The K-Tech 2 is activated with a standard low amp toggle switch. It can also be activated by running the system through commercially available optional specialty controls for the end user that does not have the ability to activate a toqgle switch. As the toqgle switch is activated, the K-Tech 2 will beqin to tilt and simultaneously move forward to center the end user's weight over the power chair base, maintaining stability of the base and end user while tilted. The K-Tech has a standard infinitely adjustable tilt range of zero to 55 degrees and custom tilt ranges are available. There is a micro-switch attached to the frame, which is activated once the end user tilts past 20 degrees, locking out the driving capabilities of the power chair for safety.
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