(244 days)
Not Known
Not Found
No
The description focuses on standard powered wheelchair components and performance testing related to speed, acceleration, and braking, with no mention of AI or ML.
No
The device provides mobility for physically challenged individuals rather than treating or diagnosing a medical condition.
No
Explanation: The device description states that the Quickie Powered Wheelchairs provide "a means of mobility" for physically challenged persons. The performance studies focus on parameters related to movement (speed, acceleration, braking, turning) and electromagnetic compatibility, ensuring the wheelchair performs as intended for mobility. There is no mention of the device being used to acquire, process, or analyze physiological data, nor to diagnose, treat, or prevent a disease or condition. Its primary function is clearly an assistive mobility device, not a diagnostic one.
No
The device description explicitly lists numerous hardware components (push handles, armrests, backrest, seat frame, cushion, footrests, casters, joystick controller, motors, brakes, batteries, drive wheels). While it mentions software validation for the controller, the device itself is a physical wheelchair with integrated hardware and software, not a software-only 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 functional purpose related to physical assistance, not diagnostic testing.
- Device Description: The description details components of a powered wheelchair, all of which are related to mobility and control. There are no mentions of reagents, samples, or analytical processes typically associated with IVDs.
- Lack of IVD Indicators: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.
The device is clearly a medical device, but its function is to provide mobility, not to perform in vitro diagnostic testing.
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 Electromagnetic compatibility testing was also wheelchairs perform according to specification. 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 and mitigation associated with the safety of the controller.
Key Metrics
Not Found
Predicate Device(s)
Not Known at the writing of this summary.
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
12963385
Appendix F
Summary of Safety and Effectiveness for Quickie Powered Wheelchair with Penny and Giles Controller
1
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.
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 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.