A&I SCOOTER, SC-402

K041193 · Well Success Biotech, Inc. · INI · May 25, 2004 · Physical Medicine

Device Facts

• Record ID: K041193
• Device Name: A&I SCOOTER, SC-402
• Applicant: Well Success Biotech, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Device Story

A&I Scooter SC-402 is a battery-operated, 4-wheeled motorized scooter for indoor/outdoor mobility. Rider operates device via hand controls on steering column. Device is disassemblable for transport; includes onboard battery charger. Electronic systems, including batteries, chargers, and controllers, are UL-certified. Device provides mobility for individuals restricted to a seated position, allowing user-controlled speed adjustment via throttle tiller. Benefits include improved personal mobility for patients with restricted physical function.

Clinical Evidence

Bench testing only. Compliance with EMC standards ANSI/RESNA WC/Vol.2-1998, CISPR 11:1990, EN61000-3-2:1995, and IEC61000-3-3:1995. Upholstery passed resistance ignition testing by SGS.

Technological Characteristics

4-wheeled motorized scooter; battery-powered; hand-controlled steering column; throttle-based speed control. Electronic components (batteries, chargers, controllers) are UL-certified. Upholstery material tested for ignition resistance.

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 3-Wheeled Neo Scooter, WT-L4Jr (K032617)

Submission Summary (Full Text)

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K041193

## WELL SUCCESS BIOTECH. INC

6F, No.70, Zi You Road, Hsinchu City, 300, Taiwan, R.O.C. FAX : [phone] TEL:[phone] E-mail:[e-mail]

## MAY 2 5 2004

## 510(k) SUMMARY " 66

Submitter's Name: WELL SUCCESS Biotech. Inc.

6F, No.70, Zi You Road, Hsinchu City, 300, Taiwan, R.O.C.

Date summary prepared:

Device Name:

Proprictary Name:

Common or Usual Name: Classification Name:

May 2, 2004

A&I Scooter, SC-402 ( Trade name: A&I, A&E, J&C ) Electrical Scooter Motorized 4-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 A&I Scooter SC-402 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the stecring 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 Scooters, controller, and their chargers requirements and test methods)

Legally marketed device for substantial equivalence comparison: WU's 3-Wheeled Neo Scooter, WT-L4Jr (K032617)

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Summary for substantial equivalence comparison:

The intended uses, the size of tires, back upholstery, and warranty period between the new device SC-402 and the predicate device WT-L4JR are all the same. Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated including the batteries, recharge, and the electronic controllers. Thus the same safety level for the two devices is assured. The major differences existing of the two Powered Scooters are the different overall dimension and weight between the two devices. The overall appearance and weight differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

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WELL SUCCESS BIOTECH 6F, No.70, Zi You Road, Hsinchu City, 300, Tai TEL:[phone] FAX : [phone] E-mail:[e-mail]

## C.2 COMPARISON SUMMARY

( We place the related information for the predicate device in the following pages. including the 510k information on the FDA website and the comparison and summary table. )

The intended uses, the size of tires, back upholstery, and warranty period between the new device SC-402 and the predicate device WT-L4JR are all the same. Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated including the batteries, recharge, and the electronic controllers. 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 maximum speed is 5.6 mph for the new device and 6.0 mph for the predicate device that are also under the 6 miles maximum speed limited. Those speeds can be continuous adjusted by the throttle tiller. The operators can set the adequate speed according to their feeling and need, and the maximum speed differences do not mean any performance differences. They are substantially cquivalent.

The major difference existing for the two devices are the overall dimension, the size of tires, and the weight are differences between the two devices. So the sizes and visual appearance among them have differences, and there is no safety level difference.

Based on the above the information and the analysis, we know that the subject device and the predicute 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 25 2004

Well Success Biotech, Inc. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K041193

Trade/Device Name: A & I Scooter, SC - 402 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: May 2, 2004 Received: May 6, 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, de nees that have been 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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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.

Sincerely yours,

Mark A. Milburn

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 1

510 (K) NUMBER ( IF KNOW ): _ TBA DEVICE NAME: A&LScooter, SC-402

INDICATIONS FOR USE:

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Prescription Use

AND/OR

()ver-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)

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

**510(k) Number** K041193