SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE

{0}------------------------------------------------ NOV 1 2 1998 K981885 #### 510(k) SUMMARY OF SAFETY AND EFFICACY 13.0 Submitter: Sunrise Medical - Mobility Products Division 7477 East Dry Creek Parkway Longmont, CO 80503 Phone (303) 218-4595 Fax (209) 218-4565 Rebecca Andersen November 5, 1998 Date: Name(s) of the device(s): Sunrise 3 Wheel Scooter Identification of predicate device(s): - 1) Quickie P190 by Sunrise Medical - 2) Quickie P120 by Sunrise Medical - 3) Sabre by Everest & Jennings - 4) Ranger II by Invacare Corporation Description of the device: The Three Wheeled mid Range Scooter is a medium duty, conventional, rear whech drive, rigid frame power Vehicle. The armrests of the sear are adjustable. The seat may be repositioned from from to back and chair height can be adjusted up and down. There are many kinds of accessories that are commonly sold after market. These accessories include canopies, crutch holders, cup holders, baskers etc. Like most scooters, the tiller and throttle controls are the user interface. They transfer the rider's intentions to command the device. When the control is activated, or moved out of neutral position, the motor brake is energized and released, allowing the scooter to move in the appropriate direction. When the activation device is released, the scooter slows to a stop and the motor brake is automatically reengaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device. If the scooter looses power, the motor brake is automatically engaged and the scooter comes to a stop. To prevent the rider from becoming stranded, the scooter may be pushed. The design incorporates a "free wheel" device motor lock disengagement device. This device allows the drive train to be manually disengaged, enabling the scooter to be pushed. It should be noted that the scooter would not have electronic brakes when in the "free wheel" mode. The controller is microprocessor based and program-able. It is pro-programmed at the manufacturer to meet Sunrise specifications. This controller is currently used on selected models of the Sunrise scooters under K880425. Drive characteristics that are pre set are: forward/reverse acceleration forward speed forward/reverse deceleration reverse speed The controller also has manual reset circuit breakers. These adjustments and features are similar to all standard scooter controllers. {1}------------------------------------------------ TEL: 303 218 4565 P. 004 The scooters have excellent performance indoors for use in shopping malls or grocery stores, and handle very well outdoors on paved surfaces, compact gravel, dry grass or other firm surfaces free from large obstacles. The Sunrise Scooter is designed to be maneuverable yet stable and powerful. That makes it the ideal moderate duty "Get out there" Scooter. Intended use: Sunrise scooters empower physically challenged persons by providing a means of mobility. ### 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 substantially equivalent, and recommended for indoor or moderate 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 ANSURESNA 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 ANSURESNA 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 Sunrise power chairs and scooters 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. Subsequent complaints against Sunrise are presented in a chart entitled "Total Sunrise Medical Power Product Complaints". The data and charts are included as Attachment 13 - A. The analysis demonstrated common issues across all manufacturer product lines, and varying levels approximately comparable to relative market share. Sunrise has concluded that there are no use issues exclusive to Sunrise chairs at this time. ## Efficacy Articles are being provided on the use and efficacy of power wheelchairs. - "Power Wheelchair Comparison", Ian Denison, 14th International Seating 1) Symposium Proceedings, pp. 113 - 116, February 1998. - 2) "Front, Back or in the Middle: Understanding Mid-Wheel Drive", Mark Greig, Sunrise Horizons, Vol I, Number 4, pp. 6 - 7, February 1998. - 3) "Dynamic Wheelchair Stability; Reliability of an Ordinal Scale", R. L. Kirby, D. A. MacLeod, R. E. Duggan, et. al., Proceedings of RESNA '97, pp. 237-239. - 4) "When Wheelchairs Tip backwards Beyond Their Stability Limits", R. L. Kirby, M. DiPersio, and D. A. MacLeod, Proceedings of RESNA '96, pp. 180 - 182. - 5) "Effect on Wheelchair Stability and Maneuverability of Varying the Position of the rear Antitip Device: A Theoretical Model", R. L. Kirby, A. V. Thoren, B. D. Ashton, and S. A. Ackroyd-Stolarz, Proceedings of RESNA '93, pp. 313 - 315, 510(k) number: K981882 - The Sunrise Scooter Series is substantially equivalent to the predicated Conclusion: devices listed in this 510(k); the technology and construction of the P190R does not raise any new issues of safety and effectiveness. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 2 1998 Ms. Rebecca Andersen Vice President, Quality/Regulatory Affairs Sunrise Medical Mobility Products Division 7477A East Dry Creek Parkway Longmont, Colorado 80503 K981885 Re: Sunrise 3 Wheel Scooter Trade Name: Requlatory Class: II Product Code: INI Dated: October 1, 1998 Received: October 7, 1998 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 Regulations, Title 21, Parts 800 to 895. ਬੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlation (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, Colia M. Witteh, Ph. D. Celya 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}------------------------------------------------ # Indications for Use Sunrise scooters empower physically challenged persons by providing a means of mobility. 510(k) number: K981885 Device name: SUNRISE SCOOTER Concurrence of CDRH, Office of Device Evaluation (ODE) □ Prescription use (per 21 CFR801.109) ष्ठ Over-the-counter use bcceeeo 1/98/885