WU'S 4-WHEELED NEO SCOOTER, WT-M3A

K082963 · Wu'S Tech Co., Ltd. · INI · Nov 24, 2008 · Physical Medicine

Device Facts

• Record ID: K082963
• Device Name: WU'S 4-WHEELED NEO SCOOTER, WT-M3A
• Applicant: Wu'S Tech Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Nov 24, 2008
• 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 3-wheeled electric scooter; provides mobility for individuals restricted to seated position. Rider operates device via hand controls on steering column. Features include seat, armrests, front basket; disassemblable for transport. Includes onboard battery charger. Used in indoor/outdoor environments. Output is physical mobility; assists patient by enabling independent movement.

Clinical Evidence

Bench testing only. Compliance with ANSI/RESNA WC/Vol.2-1998, CISPR 11:1990, EN61000-3-2:1995, and IEC61000-3-3:1995 for electromagnetic compatibility and safety of electrically powered wheelchairs and scooters.

Technological Characteristics

Battery-powered 3-wheeled electric vehicle. Materials meet strength and fatigue testing requirements. Electronic systems (controller, batteries, motors) are UL certified. Complies with ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, and IEC61000-3-3 standards. Features include suspension, armrests, footplate, and wheel lock.

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 SCOOTER WT-M4A (K072337)

Submission Summary (Full Text)

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TEL: [phone] FAX : [phone] Homepage: www.wustech.com.tw Email: [e-mail]

NOV 2 4 2008

September 28, 2008

### 66 510(k) SUMMARY "

Submitter's Name: WU'S TECH CO., LTD.

NO. 225, YUAN-PIER ST., HSIN CHU CITY, 30093, CHINA (TAIWAN)

Date summary prepared:

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

WU'S 4-WHEELED NEO SCOOTER, WT-M3A SCOOTER MOTORIZED 3-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 SCOOTER WT-M3A is an indoor / outdoor electric scooter that is battery It has a base with three-wheeled, a seat, two armrests, and a front basket. operated. 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, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: WU'S SCOOTER WT-M4A (K072337)

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

## Summary for substantial equivalence comparison:

The intended use between the two devices is the same. Mainframes of two devices are fixed. Mainframes materials of the two devices all meet the strength and fatigue tests and they are similar for the material aspects. The two devices have the same weight limit, maximum speed, incline angle, korb climbing ability, groove crossing, use the same suspension of cross brace, same size of wheels, same type of armrest, footplate, wheel lock, and same warranty. Besides, the back upholstery materials are also the same fabric and passed the resistance ignition test.

Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, motors, and Thus the same safety level for the two devices is assured. recharge.

Owing to the predicate device WT-M4A is four wheels and huger than the subject device WT-M3A is three wheels and so light that means the totally weight of the predicate device is 100kgs and the new device is 91kgs. Besides, the major differences exiting the two devices are the cruising range per charge and turn radius. The cruising range of the new device is 10~20 miles and the turn radius is 37.8", the predicate device is 10~15 miles for the cruising range and 53.1" for the turn radius. Certainly the real range depends on the practical environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wu's Tech Company, Limited % ROC Chinese-European Industrial Research Soc. Dr. Ke-Min Jen No. 58, Fu-Chiun Street Hsin-Chu City, 30067 China (Taiwan)

NOV 2 4 2008

Re: K082963

Trade/Device Name: Wu's Neo Scooter, WT-M3A Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 28, 2008 Received: October 03, 2008

Dear Dr. 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

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Page 2 - Dr. Ke-Min Jen

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Wilkerson

Mark N. Melkerson 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 510 (K) Number ( If Known ): __

Device Name: WU'S NEO SCOOTER, WT-M3A

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

(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 Newrological Devices

510(k) Number

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