WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D

K040968 · Wu'S Tech Co., Ltd. · INI · Apr 30, 2004 · Physical Medicine

Device Facts

• Record ID: K040968
• Device Name: WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D
• Applicant: Wu'S Tech Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Apr 30, 2004
• 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 indoor/outdoor electric scooter; provides mobility for individuals restricted to seated position. Features four-wheeled base, seat, armrests, front basket. Rider operates via hand controls on steering column. Disassemblable for transport; includes onboard battery charger. Used in home or community settings by patient. Output is physical mobility; healthcare provider uses device to improve patient independence. Safety verified via EMC testing.

Clinical Evidence

Bench testing only. Compliance with ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-4-2: 1995, and IEC61000-4-3: 1995 for electrically powered wheelchairs and scooters.

Technological Characteristics

Battery-operated electric scooter; four-wheeled base; hand-controlled steering column; onboard battery charger. Electronic systems (controller, batteries) are UL certified. Tested to ANSI/RESNA WC/Vol.2-1998 and IEC/EN electromagnetic compatibility standards.

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-T3D (K032488)

Submission Summary (Full Text)

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K040968

APR 3 0 2004

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

#### દ્ધ 510(k) SUMMARY "

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

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

Tel: 88

Date summary prepared:

Device Name:

Aril 10, 2003

Proprietary Name: Common or Usual Name: Classification Name:

WU'S 4-Wheeled Scooter, WT-T4D 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-T4D 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-T3D (K032488)

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

Summary for substantial equivalence comparison:

The intended uses, weight limit, back upholstery, maximum speed 4 mph, safe climbing angle 8°, and warranty period between the new device WT-T4D and the predicate device WT-T3D are all the same. Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured.

The major difference existing is 4-wheeled for new device WT-T4D and the 3-wheeled for the predicate device WT-T3D. Besides the overall dimension and the size of tires 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 seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wavy lines emanating from its body, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### APR 3 0 2004

WU'S Tech. Co., Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Rescarch Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K040968

Trade/Device Name: WU'S 4-Wheeled NEO Scooter, WT-T4D Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 10, 2004 Received: April 14, 2004

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 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milkerson

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

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Page 1 of

# 510 (K) NUMBER ( IF KNOWN ): ): TBA DEVICE NAME: WU'S 4-WHEELED NEO SCOOTER, WT-T4D

#### INDICATIONS FOR USE:

The device is intended for medical purposes to provide mobility to persons restricted to a seated 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)

Mark A. Milkerson

Division of General, Restorative. and Neurological Devices

**510(k) Number** K040968