QUICKIE P300 SERIES

K963381 · Quickie Designs, Inc. · ITI · Apr 28, 1997 · Physical Medicine

Device Facts

• Record ID: K963381
• Device Name: QUICKIE P300 SERIES
• Applicant: Quickie Designs, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Apr 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Quickie Powered Wheelchairs empower physically challenged persons by providing a means of mobility.

Device Story

Motorized wheelchair; components include joystick controller, motors, brakes, batteries, drive wheels, push handles, adjustable armrests, backrest, seat frame, cushion, footrests, casters. Input: user joystick manipulation. Transformation: P&G controller (Hitachi H8/532 microprocessor) processes joystick signals to regulate motor speed, acceleration, deceleration, and braking. Output: controlled wheelchair movement. Used in various environments by patients with physical disabilities. Healthcare provider/caregiver may assist with setup/configuration of programmable parameters (speed, acceleration, turn rates). Benefits: provides independent mobility.

Clinical Evidence

Bench testing only. Comparative testing of speed, acceleration, and braking distance confirmed performance matches predicate. Electromagnetic compatibility (EMI) testing passed at 20 V/m. Software validation included requirements, design, development, verification, validation, and hazard analysis.

Technological Characteristics

Powered wheelchair with P&G controller utilizing Hitachi H8/532 microprocessor. Programmable parameters: forward/reverse speed, turn speed, acceleration/deceleration, turn acceleration/deceleration. EMI compliance: 20 V/m.

Indications for Use

Indicated for physically challenged persons requiring powered mobility assistance.

Regulatory Classification

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.

Predicate Devices

• P100
• P110
• P190
• P500
• P200
• P210
• P320
• P300
• Earnest and Jennings Lancer 2000
• Sabre
• Sabre ES
• Prode Health Care Inc. Jazzy

Reference Devices

• Hoveround Personal Mobility Vehicles

Submission Summary (Full Text)

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CONFIDENTIAL
K963381
APR 28 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
F

{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

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.

August 22, 1996
Quickie Designs Inc. Powered Wheelchair

{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 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.

**510(k) Number** K963381

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.

August 22, 1996
Quickie Designs Inc. Powered Wheelchair
F 2