(244 days)
P100, P110, P190, P500, P500, P200, P210, P320, P300
Not Found
No
The document describes a standard powered wheelchair with a joystick controller and motors. There is no mention of AI, ML, or any features that would suggest the use of such technologies. The performance studies focus on basic parameters like speed, acceleration, and braking, which are typical for a non-AI/ML controlled device.
No
The device provides mobility, which is assistive but not therapeutic. Its function is to empower physically challenged persons by providing a means of mobility, not to treat or cure a medical condition.
No
The device description and intended use indicate that the Quickie Powered Wheelchair provides mobility. There is no mention of it being used to diagnose a medical condition or to collect data for diagnostic purposes.
No
The device description explicitly lists numerous hardware components, including motors, brakes, batteries, and drive wheels, in addition to the software controller.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "empower physically challenged persons by providing a means of mobility." This is a mechanical and assistive function, not a diagnostic one.
- Device Description: The description details components related to mobility (wheels, motors, controller, etc.), not components used for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
- Performance Studies: The performance studies focus on mobility-related parameters like speed, acceleration, braking, and electromagnetic compatibility, not diagnostic accuracy or analytical performance.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This powered wheelchair does not fit that description.
N/A
Intended Use / Indications for Use
Quickie Powered Wheelchairs empower physically challenged persons by providing a means of mobility.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 wheelchairs perform according to specification. Electromagnetic compatibility testing was also performed on Quickie Power Wheelchairs, and results demonstrate that the wheelchairs pass the 20 V/m EMI test. Software validation information includes the software requirements, design, development and verification and validation of the controller as well as a hazards analysis and mitigation associated with the safety of the controller.
Key Metrics
Not Found
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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
CONFIDENTIAL
APR 28 1997 人963382
Appendix F
Summary of Safety and Effectiveness for Quickie Powered Wheelchair with Penny and Giles Controller
・・・
1
Submitter Quickie Designs Inc. 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
P100 series
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. 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
2
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 wheelchairs perform according to specification. Electromagnetic compatibility testing was also performed on Quickie Power Wheelchairs, and results demonstrate that the wheelchairs pass the 20 V/m EMI test. Software validation information includes the software requirements, design, development and verification and validation of the controller as well as a hazards analysis and mitigation associated with the safety of the controller.
K963382 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.