QUICKIE P90 SERIES

{0}------------------------------------------------ #### 510(k) SUMMARY OF SAFETY AND EFFICACY 13.0 DEC - 2 1997 Quickie Designs, Inc. Submitter: 2842 Business Park Ave. Fresno, CA 93727 Phone (209) 292-2171 Fax (209) 292-2741 (972230 Rebecca Andersen June 9, 1997 Date: Name(s) of the device(s): P90 Power Wheelchair Series Identification of predicate device(s): - 1) Metro power by Everest & Jennings - 2) Action Power 9000 by Invacare Corporation - 3) Action Power 9000 Storm Series by Invacare Corporation ### Description of the device: Quickie P90 Power Wheelchairs consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Accessories include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As motorized wheelchairs, they also contain controllers, joysticks, motors, brakes, drive wheels and batteries. Many of these components are available in a range of sizes, shapes, angles, forms, materials or coverings. These variations allow the chairs to be configured to meet the specific desires and needs of the user. Refer to section 7 for a component diagram of a Quickie P90 chair figure 1; for nominal dimensions see figure 2. #### Intended use: Quickie powered wheelchairs empower physically challenged persons by providing a means of mobility. This includes conditions in all ages such as : - Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic Tetraplegic Quadriplegic Spina Bifida Head Injury or Trauma Muscular Dystrophy Multiple Sclerosis Polio Geriatric conditions And other immobilizing or debilitating condition {1}------------------------------------------------ # Comparison of device characteristics to predicate(s): This device has similar technological characteristics as the predicated devices. They all use steel and aluminum in their frame and components, and standard foams and covers for the slings and backs. Microprocessors are typically used with a programmable controller, and the rider controls the chair using a joystick or other equivalent command mode. Motors use permanent magnets, employing 24 volt D.C., with rechargeable deep cycle batteries for an energy source. The operating speeds and maneuverability are equivalent, and recommended for indoor or light outdoor use. The standard accessories and components are common to all power wheel chair lines. # Testing: This device has been tested to both ISO7176 and ANSI/RESNA Wheelchair Standards. They include: Static Stability Dynamic Stability Effectiveness of Brakes Energy consumption Overall Dimensions Maximum Speed acceleration and retardation Static Impact Fatigue Strength Climatic Test Obstacle Climbing Ability Testing of Power and Control System EMC Testing We have also tested to the Proposed : Addition to ANSI/RESNA W/C 14 Electromagnetic Compatibility Requirements for powered Wheelchairs and Motorized Scooters Version 1.5 Dated 1/11/94 ISO EMC Draft Standard 7176-14 Rifled Draft ISO EMC Group Proposal Electromagnetic Compatibility Addition Dated 4/3/95 Regarding Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters. {2}------------------------------------------------ # Safety: An analysis of complaints against Quickie power chairs was completed and charted. This analysis was supported by a literature search which was conducted by a third party to determine the number of complaints, MDR's and recalls that have been reported to the FDA concerning wheelchairs in general. This information was summarized, and presented in a Management Review report dated 2/20/97. The data and charts are included as Attachment 13 - A. The analysis demonstrated common issues across all manufacturers product lines, and varying levels approximately comparable to relative market share. Quickie has concluded that there are no use issues exclusive to Quickie chairs at this time. ## Efficacy Articles are being provided on the use and efficacy of power wheelchairs. - 1) "A Question of Power", Team Rehab Report, by Robbie B. Leonard, MS, PT, pp. 22-23, May 1992 - 2) "Preventing occupied wheelchairs from falling down stars", Journal of Rehabilitation Research, by R. Lee Kirby, MD. And Angus D. MCLean, Dip Eng Bsc., PP 27 - 32, Vol. 27 No. 1. Winter 1990. - 3) "Powered Mobility and Its Implications", JRRD Clinical Supplement, by C. Gerald Warren, pp. 74 - 85, Technical Paper. 510(k) number: Not assigned at the writing of this summary # Conclusion: The Ouickie P90 Power Wheelchair is substantially equivalent to the predicated devices listed in this 510(k) and the technology and construction of the P90 does not raise any new issues of safety and effectiveness. {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird with outstretched wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Rebecca Andersen ·Vice President, Quality and Regulatory Affairs Sunrise Medical Mobility Products Division 7477 A East Dry Creek Parkway 80503 Longmont, Colorado DEC - 2 1997 K972230 Re: P120 Series Requlatory Class: II Product Code: ITI Dated: September 4, 1997 Received: September 9, 1997 Dear Ms. Andersen: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {4}------------------------------------------------ Page 2 - Ms. Rebecca Andersen This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ | Page | | Ol | | |------|---|----|--------------------| | | 1 | 1 | Annual Property of | | 510(k) Number (if known): | K972230 | |---------------------------|------------------------------| | Device Name: | Quickie P90 (New Home P-120) | Indications For Use: Please amend Section 12.2, Indications for Use as found on Page 58 to read: Quickie powered wheelchairs empower physically challenged persons by providing a means of mobility. This included conditions in all ages such as: Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic Tetaplegic (Quadraplegic) Spina Bifida Head Injury or Trauma Muscular Dystrophy Multiple Scierosis Polio Geriatric Conditions And other immobilizing or debilitating conditions (PLEASE DO NOT WRITE: BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) of General Restora 510(k) Number Prascription Use (Per 21 CFR 801. 109) CA Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) . "