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510(k) Data Aggregation

    K Number
    K131336
    Device Name
    TX WHEELCHAIR CHASSIS
    Date Cleared
    2013-10-28

    (172 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    JCM SEATING SOLUTIONS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TX Wheelchair Chassis is designed and manufactured by JCM Seating Solutions for the mobilization of occupants ages 2 to adult, and intended primarily for general indoor and outdoor (smooth surfaces) use. The chassis and seating system combination can also be used for transporting the occupant in a suitable motor vehicle.
    Device Description
    The TX Wheelchair Chassis is designed and manufactured by JCM Seating Solutions for the mobilization of both our own postural seating systems and those manufactured by other specialist seating providers, and is indicated for occupants ages 2 to adult, and intended primarily for general indoor and outdoor (smooth surfaces) use. The chassis consist of a fabricated steel framework with two rear wheels and two front castors where both front and rear wheel sizes can be selected at point of order from a pre-determined range. The TX Wheelchair Chassis also has a "tilt in space" feature that allows for the user's position in space to be changed between -30°/+5°, which may lead to improvements in postural stability and comfort, contributing to enhanced functional activity. A push handle is provided to enable an attendant to propel the chassis and the seated occupant and under certain circumstances the product could be setup to enable the occupant to self-propel through the rear wheels themselves. The chassis and seating system combination can also be used for transporting the occupant in a suitable motor vehicle and has tie-down points to facilitate this.
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