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510(k) Data Aggregation

    K Number
    K050264
    Device Name
    STEALTH PRODUCTS SEATING SYSTEM
    Manufacturer
    Date Cleared
    2005-02-11

    (7 days)

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

    STEALTH PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Stealth Products Powered Seating System is to provide pressure relief to persons confined to a wheelchair, by providing a method of tilting and reclining the wheelchair seat and back. The intended function and use of the Stealth Products Powered Seating System for Power Wheelchairs is to provide pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back.
    Device Description
    The Stealth Products Powered Seating System for power wheelchairs is a battery powered, motorized seating system, designed for use with power wheelchairs. It's intended function and use is to provide pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back. The system consists primarily of a main frame assembly, a system mounting plate, linear actuators and a toggle switch assembly. The main frame assembly supports the patient during use of the seating system. The system mounting plate is the interface between the Stealth Seating System and the wheelchair. The linear actuator provides the motion needed to position the system, and the toggle switch assembly is the means by which the tilt/recline functions are activated. The Stealth Powered Seating System is designed to adapt to wheelchairs with round, square, or rectangular frames. Minimum frame requirements are 1 ½" diameter x .09 wall for round frames and a 1" mounting surface x .09 wall for square and rectangular frames.
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