← Product Code [INI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI) · K050042 # WU'S 4-WHEELED NEO SCOOTER, WT-XL4 (K050042) _Wu'S Tech Co., Ltd. · INI · Mar 14, 2005 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K050042 ## Device Facts - **Applicant:** Wu'S Tech Co., Ltd. - **Product Code:** [INI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI.md) - **Decision Date:** Mar 14, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.3800 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for Use The device is intended for medical purposes to provide mobility to persons restricted to a seated position. ## Device Story Battery-operated 4-wheeled electric scooter for indoor/outdoor use; provides mobility for individuals restricted to seated position. Rider operates device via hand controls on steering column. Features include seat, armrests, and front basket; disassembles for transport. Includes onboard battery charger. Electronic systems (controller, batteries, charger) sourced from same suppliers as predicate. Output is physical mobility for patient. Used in various environments by patient. ## Clinical Evidence Bench testing only. Compliance with EMC standards ANSI/RESNA WC/Vol.2-1998, CISPR 11:1990, EN61000-4-2:1995, and IEC61000-4-3:1995. ## Technological Characteristics Battery-operated 4-wheeled electric scooter. Includes controller, batteries, and onboard charger. Complies with ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-4-2, and IEC61000-4-3. Weight capacity: 550 lbs. ## Regulatory Identification A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons. ## Predicate Devices - WU'S 4-WHEELED NEO SCOOTER WT-LA ([K013763](/device/K013763.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K050042 MAR 1 4 2005 WU'S TECH CO., LTD NO. 225, YUAN-PIER ST., HSIN CHU CITY, CH TEL: 886-3-5382105 FAX - 886-3-53871 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net ## 46 510(k) SUMMARY " Submitter's Name: WU'S TECH CO., LTD. NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) Date summary prepared: Device Name: December 30, 2004 Proprietary Name: Common or Usual Name: Classification Name: WU'S 4-Wheeled Scooter, WT-XL4 Electrical Scooter Motor Three-Wheeled Vehicle, Class II. 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 WU'S 4-WHEELED SCOOTER WT-XL is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses 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, EN61000-4-2: 1995, IEC61000-4-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods) Legally marketed device for substantial equivalence comparison: WU'S 4-WHEELED NEO SCOOTER WT-LA (K013763) {1}------------------------------------------------ NO. 225. YUAN-PIER ST., HSIN CHU CITY, C TEL: 886-3-5382105 FAX: 886-3-5382 Email: wustis@ms45.hinet.net Homepage: www.wustech.com.tw Summary for substantial equivalence comparison: The intended uses, similar batteries, cruising range, back upholstery, armrest types, and warranty period between the new device WT-XL4 and the predicate device WT-L4 are all the same. Especially the electronic systems between two devices, except the recharge are the different suppliers, they are the same suppliers and all passed by the UL certificated, for instance the controller, the batteries and recharge and switching power supplier. Thus the same safety level for the two devices is assured. The major differences existing of the two scooters are the new device WT-XLA is huger for the patients that weight limit are 550 lbs and the predicate device WT-L4 is for general use for the 300 lbs patients. Thus the new device needs bigger the overall dimension, the size of tires, and the weights are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white. MAR I = 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dr. Ke Min Jen Official Correspondent Wu's Tech Co., LTD. No. 225, Yuan-Pier St. Hsin Chu City, China (Taiwan) Re: K050042 Trade/Device Name: Wu's 4- Wheeled Neo Scooter, WT-XL4 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three wheeled vehicle Regulatory Class: II Product Code: INI Dated: February 17, 2005 Received: February 22, 2005 Dear Dr. Ke Min Jen: 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. {3}------------------------------------------------ Page 2 -Dr. Ke Min Jen 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/cdrl/industry/support/index.html. Sincerely yours, L. Mark A. Millman Miriam C. Provost, Ph.D. 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 05004 510 (K) Number ( If Known ): _________________________________________________________________________________________________________________________________________________ Device Name: WU'S 4-WHEELED NEO SCOOTER,WT-XL4 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 NEEDE! Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, R and Neurological Page 1 of _ 510(k) Number K050042 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K050042](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K050042) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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