WU'S 4-WHEELED NEO SCOOTER, WT-XL4

K050042 · Wu'S Tech Co., Ltd. · INI · Mar 14, 2005 · Physical Medicine

Device Facts

• Record ID: K050042
• Device Name: WU'S 4-WHEELED NEO SCOOTER, WT-XL4
• Applicant: Wu'S Tech Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Mar 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Indications for Use

Indicated for persons restricted to a seated position requiring mobility assistance.

Regulatory Classification

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)

Submission Summary (Full Text)

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K050042

MAR 1 4 2005

WU'S TECH CO., LTD

NO. 225, YUAN-PIER ST., HSIN CHU CITY, CH TEL: [phone] FAX - 886-3-53871 Homepage: www.wustech.com.tw Email: [e-mail]

## 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)

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NO. 225. YUAN-PIER ST., HSIN CHU CITY, C TEL: [phone] FAX: [phone] Email: [e-mail] 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.

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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.

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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 [phone] . 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 [phone] or [phone] 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

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## 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

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510(k) Number K050042