LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021

{0}------------------------------------------------ Image /page/0/Picture/0 description: This image shows the letterhead for Lerado China Limited. The letterhead includes the company logo, address, phone number, fax number, email address, and website. The address is Unit 18, 17F, China Merchants Tower, Shun Tak Center, 168-200 Connaught Rd., Central, HK, China. The phone number is 886-5-2475520, and the fax number is 886-5-2379672. The email address is edwardL@mail.lerado.com, and the website is http://www.lerado.com. The letterhead also includes the date AUG 31 2005 and the number K051473. ## 510(k) SUMMARY " 66 Submitter's Name: LERADO CHINA LIMITED Unit 18, 17F, China Merchants Tower, Shun Tak Center, 168-200 Connaught Rd., Central, HK, China Date summary prepared: Device Name: LERADO, AVANTICARE Electrical Scooter, SM3021 Proprietary Name: Electrical Scooter Common or Usual Name: Motorized 3-Wheeled Vehicle, Class II, Classification Name: 21 CFR 890.3800 Indications for Use: The device is intended for medical purposes to provide mobility to persons restricted to a seated position. Description of the device: The LERADO, AVANTICARE Electrical Scooter SM3021 is an indoor / outdoor Electrical Scooter that is battery operated. It has a base with three-wheeled The movement of the Wheelchair is controlled by the rider who uses with a seat. hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger. Performance Testing: EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Electrical Scooters, controller, and their chargers requirements and test methods) Legally marketed device for substantial equivalence comparison: WU'S Wheeled Neo Scooter WT-T3B (K023168) May 29, 2005 {1}------------------------------------------------ LERADO CHINA LIMITED Unit 18, 17F, China Merchants Tower, Shun Tak Center, 168-200 Connaught Rd., Central, HK, China Fax: 886-5-2379672 Tel: 886-5-2475520 http:// www.lerado.com E-mail:edwardL@mail.lerado.com Summary for substantial equivalence comparison: The intended uses, back upholstery, armrest types, and warranty period between the new device SM3021 and the predicate device WT-T3B are all the same. Especially the electronic systems between two devices, except the electric controllers are the different suppliers, they are the same suppliers and all passed by the UL certificated, for instance the batteries, recharge and switching power supplier. Thus the same safety level for the two devices is assured. The cruising range of the new device is 10 miles for the predicate device. This is mainly due to the fact that the batteries for the two devices are smaller. Certainly the real range depends on the practice environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent. The weight limit differences existing of the two scooters that the new device SM3021 weight limit is 300 lbs and the predicate device WT-T3B is 250 lbs. Besides, the maximum speed for the new device is 4.7 mph and 4 mph for the predicate device. To sum up the mainly different of the two devices are only appearance dimensions, i.e., the overall dimensions, the size of wheels, seat dimensions, weight limit, and maximum speed. For the regular operator, these differences for the two devices do not lead to any performance differences, and the two devices are substantially equivalent. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures in profile, stacked on top of each other. AUG 3 1 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Lerado China Limited c/o Dr. Jen Ke-Min ROC Chinese-European Industrial Research Society No. 58 Fu-Chiun Street Hsin-Chu City, 30067, Taiwan, ROC Re: K051473 K051475 Trade/Device Name: LERADO, AVANTICARE SCOOTER SM3021 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 8, 2005 Received: August 15, 2005 Dear Dr. Ke-Min: We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 5 ro(x) premainer is substantially equivalent (for the indications for use stated in the enclosure and as a research and evices marketed in interstate for use stated in the encrosule) to regary maneton in the Medical Device American son to commerce prior to May 20, 1970, the enactives with the provisions of the Federal Food. Drug, devices that have been reclassified in acceraance while and rowal approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval appl and Cosmetic Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, uteretore, manset the actives, solorements for annual registration, listing of general controls provisions of the rist lice 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 ( If your device is classified (see above) fine exist reass ajor regulations affecting your device can may be subject to such additional controls. Existing major regulations o may be subject to such additional combines, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I sacral singerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a backed complies with other requirements of the Act that FDA has made a delerimmation administered by other Federal agencies. You must or any Federal statutes and regulations adminding, but not limited to: registration and listing (21 comply with an the Act 3 requirements) methods. CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice that has best a CFR Part 807), labeling (21 CFR Part 800); good market 820); and 1f applicable, the electronic and form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ ## Page 2- Dr. Jen Ke-Min This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maneting of substantial equivalence of your device to a legally prematket notification. The PDA miding of saostaliana equal managements your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac not 10-11-2 Also, please note the regulation entitled, a Contact the Office of Complance at (210) = 1.6 = 1.6 = 1.6 = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 "Misbranding by relevence to premainteriouslibilities under the Act from the Division of Small other general information on your respensions at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance at its toll-the states and Manufacturers, International and Consumers andress http://www.fda.gov/cdrh/dsmamain.html Sincerely yours, Mark N. Mulkerzen Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use K 510 (K) Number ( If Known ): _________________________________________________________________________________________________________________________________________________ Device Name: LERADO, AVANTICARE SCOOTER SM3021 Indications for Use: The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ V (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K051473 Page 1 of 1