POWER SCOOTER, MODEL TL0821

{0}------------------------------------------------ ## TEH LIN PROSTHETIC & ORTHO No. 7, Wu Chuan 7th Road, WuKu Industrial Park, Taipei County, Taiwan R.O.C. Telephone: 886-2-22991901 Fax: 886-2-22991030 E-mail: tlco@ms2.hinet.net http://www.tehlin.com.tw SEP 2 4 200 / K042011 July 22, 2004 #### ર્દ 510(k) SUMMARY " Submitter's Name: TEH LIN Prosthetic & Orthopaedic Inc. No. 7, Wu Chuan 7th Road, WuKu Industrial Park, Taipei County, Taiwan R.O.C. Date summary prepared: Device Name: > Proprietary Name: Common or Usual Name: Classification Name: TEH LIN Power Scooter, TL-821 Powered Scooter Powered Scooter, Class II. 21 CFR 890.3860 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 TEH LIN Powered Scooter, TL-821 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-whecled with a seat. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the The device can be disassembled for transport and is provided with steering column. 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 Powered Scooters, controller, and their chargers requirements and test methods) Legally marketed device for substantial equivalence comparison: TEH LIN POWER SCOOTER TL-588(K022698) {1}------------------------------------------------ ## TEH LIN PROSTHETIC & ORTHOPAEDIC INC. No. 7, Wu Chuan 7th Road, WuKu Industrial Park, Taipei County, Taiwan R.O.C. Telephone: 886-2-22991901 Fax: 886-2-22991030 E-mail: tlco@ms2.hinet.net http://www.tehlin.com.tw #### C.2 COMPARISON SUMMARY ( We place the related information for the predicate device in the following pages, including the visual appearance, 510k information on the FFDA website, and the comparison and summary table. ) According to the above table that the intended use between two devices is the same, The batteries used are the same brand and same type that is certified by UL. The control systems for the two devices are same brand i.e., Penny & Giles for the two devices. The recharge for the two devices are used the same resource, HP8204A, and the recharger is certified by UL. Besides, the foldable frame, removable arm type, same tires, same seat size, same warranty on component and frame, and back upholstery are the same material that also be passed the resistance ignition test by SGS. The overall dimensions, weight limit, and weight capabilities differences between two devices are small, and the dimensions for the new device are larger than those of the predicate device. The device of the smaller dimensions can be fitted into most of the ordinary car trunk. The cruising range of the new device is 37 km and 40 km 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 safety climbing abilities for the two devices are different, the new device is 12° and 15° for the predicate device. We place the relevant specification of maximum climbing ability 12° in the owner's manual. The user's climb is not allowed to exceed 12° for the new device. In this sense the two devices are substantially equivalent. The maximum speed is 5.6 mph for the new devices and 5 mph for the predicate device. The throttle tiller can continuously adjust the speeds. The operators can set the adequate speed according to their feeling and need, i.e., outdoor or indoor. This means thee two devices have the same safety and hazard. Based on the above the information and the analysis, we know that the subject device and the predicate device have the same intended use, the same technological aspects and only minor differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent. {2}------------------------------------------------ # TEH LIN PROSTHETIC & ORTHOPAEDIC INC. No. 7, Wu Chuan 7th Road, WuKu Industrial Park, Taipei County, Taiwan R.O.C. Telephone: 886-2-22991901 Fax: 886-2-22991030 E-mail: tlco@ms2.hinet.net http://www.tehlin.com.tw Summary for substantial equivalence comparison: The intended use between the two devices is the same. The batteries used are the same brand and same type that is certified by UL. The control systems for the two devices are same brand i.e., Penny & Giles for the two devices. The recharge for the two devices are used the same resource, HP8204A, and the recharger is certified by UL. Besides, the foldable frame, removable arm type, same tires, same seat size, same warranty on component and frame, and back upholstery are the same material that also be passed the resistance ignition test by SGS. Thus the same safety level for the two devices is assured. The major differences existing of the two Power Scooters are the different overall dimension, weight limit, weight capabilities, climbing angle, cruising range, and maximum speed between the two devices. Based on the above the information and the analysis, we know that the subject device and the predicate device have the same intended use, the same technological aspects and only minor differences exist. So the new device is substantially equivalent to the predicate devices in this aspect. {3}------------------------------------------------ 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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white. SEP 2 4 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Teh Lin Prosthetic & Orthopaedic, Inc. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300 Re: K042011 Trade/Device Name: Teh Lin Power Scooter, TL-821 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 31, 2004 Received: September 7, 2004 Dear Dr. Jen: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revioused your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Ior use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered pror to may 2011 - 3) in accordance with the provisions of the Federal Food, DNA 4 devices that have been recuire approval of a premarket approval application (PMA). and Cosmetter rect (1101) that to novice, subject to the general controls provisions of the Act. The r ou may, dierelove, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is classified (600 a00 70) als. Existing major regulations affecting your device can may or defect to deciritions, 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 I loase oc devilsed that I DTT o levice complies with other requirements of the Act that I Drimas made a sond regulations administered by other Federal agencies. You must of any I cuteral statutes and regarities, including, but not limited to: registration and listing (21 comply with an the 110 - 11 CFR Part 801); good manufacturing practice requirements as set CITY at 007); adoming (Dr CFR egulation (21 CFR Part 820); and if applicable, the electronic forth in the quisions of of the Actions 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ ### Page 2 - Dr. Ke-Min Jen This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you'ts obgen maing of substantial equivalence of your device to a legally premaired predicated 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 if you deem's specific arrangliance at (301) 594-4659. Also, please note the regulation entitled, Connact the Office or Cremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorinational 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, Mark A. Milkerss Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page 1 of 1 ## 510 (K) NUMBER ( IF KNOW ):__ TBA DEVICE NAME: TEH LIN POWER SCOOTER, TL-821 INDICATIONS FOR USE: The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. Prescription Use AND/OR Over-The-Counter Use __ (Part 21 CFR 801 Subpart D) (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 Neurologica. Devices 510(k) Number K042011