WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H

K091212 · Wu'S Tech Co., Ltd. · INI · May 27, 2009 · Physical Medicine

Device Facts

• Record ID: K091212
• Device Name: WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H
• Applicant: Wu'S Tech Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: May 27, 2009
• 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 sitting position.

Device Story

Battery-operated 3-wheeled electric scooter; indoor/outdoor use. Rider-controlled via hand-operated steering column interface. Features seat, armrests, front basket; disassemblable for transport. Includes onboard battery charger. Provides mobility for individuals restricted to seated position. Safety features include UL-certified electronic systems (controller, batteries, charger) and ignition-resistant back upholstery.

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. Back upholstery passed resistance ignition testing by SGS.

Technological Characteristics

3-wheeled motorized vehicle; battery-powered. Electronic systems (controller, batteries, charger) are UL-certified. Back upholstery material tested for ignition resistance. Dimensions and weight differ from predicate. No software-based algorithms.

Indications for Use

Indicated for persons restricted to a sitting 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-T3D (K032488)

Submission Summary (Full Text)

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WUS TECH CO., LTD. K091212

NO. 225. YUA TEL: [phone] Homepage: www.wustech.com.tw Email: [e-mail]

> 2 7 2009 MAY

## 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:

April 17, 2009

Proprietary Name: WU'S 3-WHEELED ELECTRICAL SCOOTER, WT-T3H Common or Usual Name: SCOOTER Classification Name: 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-T3H is an indoor / outdoor electric scooter that is battery.
anavated on Indo operated. It has a base with three-wheeled, a seat, two 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, EN61000-3-2: 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-T3D (K032488)

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

### C.2 COMPARISON SUMMARY

( We place the related information for the predicate device in the following pages. )

The intended uses, weight limit 250 lbs, maximum speed 4 mph, safety climbing angle 8°, back upholstery, and warranty period between the new device WT-T3H and the predicate device WT-T3D are all the same. Especially the electronic systems between two devices are all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Thus the same safety level for the two devices is assured.

The new device is more simple and easy to use, thus the major difference existing for new device is the overall dimension, the size of tires, weight, and the cruising range are differences between the two devices. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.

Based on the above the information and the analysis, we know that the subject device and the predicate devices have the same intended use, the same technological aspects and only minor dimensions or data differences exist. `We believe that FDA can decide the subject device and the predicate device are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a simple, clean design.

Public Health Service

MAY 27 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K091212

Trade/Device Name: WU'S ELECTRICAL SCOOTER, WT-T3H Regulation Number: 21 CFR 890.3800 Regulation Names: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 17, 2009 Received: April 27, 2009

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lead be advised a determination that your device complies with other requirements of the Act that I Dr has intable and regulations administered by other Federal agencies. You must or any I outhar state are are requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical of it far overy, accemig (21 CFR 803); good manufacturing practice requirements as set de receited daverse overies (2) 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

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely vours

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use

K 09/2/2 510(k) Number:

Device Name: WU'S ELECTRICAL SCOOTER, WT-T3H

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 Surgical, Orthopedic, and Restorative Devices

510(k) Number K091212

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