(244 days)
Quickie Powered Wheelchairs empower physically challenged persons by providing a means of mobility.
Quickie powered wheelchairs consist of typical features found on any wheelchair, such as push handles, adjustable armrests, backrest, seat frame and cushion, footrests, and casters. Because these are motorized wheelchairs, they also consist of joy stick controller, motors, brakes, batteries and drive wheels.
This document is a 510(k) premarket notification for a change in the controller of an existing powered wheelchair. It does not describe a study involving "acceptance criteria" and "device performance" in the context of typical AI/ML medical device evaluations.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device due to a controller change, not on evaluating the performance of a new AI/ML algorithm against predefined metrics.
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CONFIDENTIAL
APR 28 1997
12963385
Appendix F
Summary of Safety and Effectiveness for Quickie Powered Wheelchair with Penny and Giles Controller
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Quickie Designs Inc. Submitter 2842 Business Park Ave. Fresno, CA 93727 Fax-209-292-2741 209-292-2171 Dave Counts
Date summary was prepared 8/21/1996
Name(s) of the device
P200 series ( P200, P210, P320) Identification of predicate device(s) P100, P110, P190, P500, P500, P200, P210, P320, P300 Everest and Jennings Lancer 2000, Sabre, Sabre ES Prode Health Care Inc. Jazzy
Description of the device
Quickie powered wheelchairs consist of typical features found on any wheelchair, such as push handles, adjustable armrests, backrest, seat frame and cushion, footrests, and casters. Because these are motorized wheelchairs, they also consist of joy stick controller, motors, brakes, batteries and drive wheels.
Intended Use
Quickie Powered Wheelchairs empower physically challenged persons by providing a means of mobility.
Comparison of device characteristics to predicate
This 510(k) is for a change in the wheel chair controller. The power wheelchair specifications have not been changed due to this modification. The New controller subject to this 510(k) is the P&G Controller that has been available on other lines of power wheelchairs, including Pride Health Care's Jazzy, Everst and Jennings Lancer 2000 and Sabre, and Hoveround Personal Mobility Vehicles.
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Everest and Jennings recently made the same switch in controllers as Quickie; replacing the Dynamics Controller with a P&G 8 controller.
The P&G controller is based on Hitachi's H8/532 microprocessor while Dynamics is based on Motorola's 68HC705C8. The power wheelchair specifications have not been changed due to this modification.
Non clinical testing
Testing of all programmable parameters has been performed. These parameters include the following: maximum and minimum forward and reverse speeds, maximum and minimum turn speeds, maximum and minimum acceleration and deceleration, and maximum and minimum turn acceleration and deceleration. Comparative testing regarding speed, acceleration, brake distance demonstrate that the wheelchair performs as the predicate device with the Dynamics controller. Results demonstrate the Electromagnetic compatibility testing was also wheelchairs perform according to specification. performed on Quickie Power Wheelchairs, and results demonstrate that the wheelchairs pass the 20 Software validation information includes the software requirements, design, V/m EMI test. development and verification and validation of the controller as well as a hazards and mitigation associated with the safety of the controller.
K963385 510(k) Number
Not Known at the writing of this summary.
Conclusion
The Quickie Power Wheelchair is Substantially Equivalent to the previous versions of the Quickie Wheelchairs which utilize the Dynamics controller as well as other power wheelchair models which already incorporate the P&G 8 controller.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).