(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 is a mobility aid for physically challenged persons, not a device intended to treat or manage a disease or condition.
No
The device description and intended use indicate that it is a powered wheelchair designed for mobility, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly lists numerous hardware components including motors, brakes, batteries, and drive wheels, indicating it is a physical device with integrated software, not a software-only medical device.
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 function for physical assistance, not a diagnostic test performed on biological samples.
- Device Description: The description details components of a wheelchair, such as motors, batteries, and a joystick controller. These are all related to mobility and control, not to analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no reagents, assays, or procedures related to diagnosing a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. 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 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.
Key Metrics
Not Found
Predicate Device(s)
P100, P110, P190, P500, P500, P200, P210, P320, P300 Earnest 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
APR 2 8 1997
Appendix F
Summary of Safety and Effectiveness for Quickie Powered Wheelchair with Penny and Giles Controller
August 22, 1996
Quickie Designs Inc. Powered Wheelchair
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1
Submitter Quickie Designs Inc. 2842 Business Park Ave. Fresno, CA 93727 209-292-2171 Fax-209-292-2741 Dave Counts
Date summary was prepared 8/21/1996
Name(s) of the device
P300
Identification of predicate device(s) P100, P110, P190, P500, P500, P200, P210, P320, P300 Earnest 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
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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.
2
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 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 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.
K963381 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.