VCS S3Y

{0}------------------------------------------------ KOS//JO 7. 510(k) summary SEP - 9 2005 # 510(k) Summary ## VEHICLES TECHNOLOGY CO., LTD. ### VCS S3Y scooter Sponsor's information: Cycling and Health Tech Industry R&D Center No. 17, 37th Rd., Taichung Industry Park, Taichung, Taiwan, 40768 Contact person: Dr. Chang Wan-Lan Director of Testing Department Phone: +886-4-23501100 Facsimile: +886-4-23504590 e-mail: cwl@tbnet.org.tw Date prepared: April 22, 2005 Proprietary and Manufacturer information: VEHICLES TECHNOLOGY CO., LTD. No. 238, San Tsun 1st, Yung Kang City, Tainan, Taiwan, 71072 Registration number: 3005037465 Contact person: Chun-Pi Shen, Manager Phone: +886-6-2436477 Facsimile: +886-6-2436479 e-mail: vcs.power@msa.hinet.net #### Device Trade name: VCS S3Y scooter Common name: Electrical scooter Classification name: Motorized three-wheeled vehicle Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3800 Product Code: 89INI Classification: Class II {1}------------------------------------------------ K05//30 2/3 #### Predicate devices Manufacture name: TUNG DENG ENTERPRISE CO., LTD. Name: Be-Mobile 3-Wheeled Electric Scooter, DK S320 k number: K033241 Date cleared: 11/10/2003 #### Intend use of device VCS S3Y scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position. #### Device description: The VCS S3Y scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The VCS S3Y scooter is with a 136 kg (300 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steef frame, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 25 km (15 miles) with 21 AH which maximum speed upto 8.6 km/hr (5.4 mph). #### Substantial equivalence: The VCS S3Y scooter is substantially equivalent to the Be-Mobile 3-Wheeled Electric Scooter, DK S320 (K033241) manufactured by TUNG DENG ENTERPRISE CO., LTD.. Analysis of comparison of design, function and feature of VCS S3Y scooter to TUNG DENG DK S320 (K033241), together with the results of compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended. While there are minor differences in performance specifications of the scooters, {2}------------------------------------------------ # KOS1130 J/J these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Vehicles believes that the VCS S3Y scooter is substantially equivalent to legally marketed devices currently in commercial distribution. #### Non-Clinical testing VCS S3Y scooter has been tested to wheelchair standards. They include: - (1). ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 Determination of static stability - (2). ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods - (3). ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters - (4). CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics -- limits and methods of measurement - (5). IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD) - (6). IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, clectromagnetic field immunity test - (7). California Bureau of Home Furnishings 116 Flammability Standards. {3}------------------------------------------------ Public Health Service Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head and body. SEP - 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dr. Chang Wan-Lan Director of Testing Department Cycling and Health Tech Industry R & D Center No. 17, 37" Road Taichung Industry Park Taichung, Taiwan 40768 China Re: K051130 Trade/Device Name: VCS S3Y Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 24, 2005 Received: September 2, 2005 Dear Dr. Wan-Lan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ Page 2 - Dr. Chang Wan-Lan This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Neil R.P. Ogle Mark N. Miller Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure 1 {5}------------------------------------------------ 3. Device descriptive information 3.1 Statement of indication for use ## Statement of Indications for Use 510(k) Number (if known): _K051130 Device Name: VCS S3Y Indications for Use: The VCS S3Y scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. Prescription Use Over-The-Counter Use X_ (Part 21 CFR 801 Subpart D) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 (Division Sign-Off) (Division of General, Restorative, and Neurological Devices K051130 510(k) Number- (Posted November 13, 2003)