A&I POWER WHEELCHAIR, PC-401

K041190 · Well Success Biotech, Inc. · ITI · May 25, 2004 · Physical Medicine

Device Facts

• Record ID: K041190
• Device Name: A&I POWER WHEELCHAIR, PC-401
• Applicant: Well Success Biotech, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• 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

A&I Power Wheelchair, PC-401 is a battery-operated, four-wheeled indoor/outdoor powered wheelchair. Rider operates device via hand controls on steering column. Device features foldable frame, removable armrests, and is transportable via disassembly. Onboard battery charger included. Device provides mobility for users restricted to seated position. Performance verified against ANSI/RESNA WC/Vol.2-1998 and electrical safety standards (CISPR 11, EN61000-3-2, IEC61000-3-3).

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.

Technological Characteristics

Battery-operated powered wheelchair; four-wheeled base; foldable frame; removable armrests. Electronic control system (Dynamic type). Onboard battery charger (HP8204A). Materials passed resistance ignition test by SGS. Complies with ANSI/RESNA WC/Vol.2-1998.

Indications for Use

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

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• SINON Power Wheelchair, SN-W401 (K040319)

Submission Summary (Full Text)

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K041190

## WELL SUCCESS BIOTECH. INC.

MAY 25 2004 6F, No.70, Zi You Road, Hsinchu City, 300, Taiwan, R.O.C. TEL:[phone] FAX : [phone] E-mail:[e-mail]

#### 66 510(k) SUMMARY "

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:

vice Name.

Proprietary Name:

Common or Usual Name: Classification Name:

A&I Power Wheelchair, PC-401 (Trade name: A&I, A&F, J&C ) Powered Wheelchair Powered Wheelchair, Class II, 21 CFR 890.3860

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 Power Wheelchair, PC-401 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of The device can be disassembled for transport and is provided the stecring column. with an onboard battery charger,

Performance Testing:

FMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: SINON Power Wheelchair, SN-W401 (K040319)

April 30, 2004

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#### WELL SUCCESS BIOTECH. INC. 6F, No.70, Zi You Road, Hsinchu City, 300, Taiwan, R.O.C. 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 visual appearance, 510k information on the FDA website, and the comparison and summary table. )

According to the above table that the intended use between two devices is the same. The batteries used are the same brand and similar U1 type that is certified by UI.. The control systems for the two devices are same brand i.e., Dynamic types for the two devices. The recharge for the two devices are used the same resource, HP8204A, and the recharger is certified by UL. - Besides, the foldable frame, removable arm type, same warranty on component and frame, weight limit, and back upholstery are the same material that also be passed the resistance ignition test by SGS.

The cruising range of the new device is 20~30 km and 32 km for the predicate device. This is mainly due to the fact that the new device uses smaller batteries. Certainly the real range depends on the practice environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.

The maximum speed for the new device is 4.4 mph and 4 mph for the predicate The similar speed means the two devices shall also meet the relevant device. requirements for the braking time, distance, and dynamic stability for safety considerations. The different maximum speeds do not lead any safety considerations and they are substantially equivalent in this aspect.

The safety climbing abilities for the two devices are same 12°. Furthermore, we place the relevant specification of maximum climbing ability 12° in the owner's manual. The user's climb is not allowed to exceed 12° for the new device. I In this sense the two devices are substantially equivalent.

To sum up the mainly different of the two devices are only appearance dimensions, i.e., the overall dimensions, the size of wheels, and seat dimensions. For the regular operator, these differences for the two devices do not lead to any performance differences, and the two devices are substantially equivalent.

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

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## 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]

Summary for substantial equivalence comparison:

The electronic systems between two devices are the same 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 differences existing of the two Powered Wheelchairs are the different overall dimension and weight between the two devices. The overall appearance and weight differences are not safety So the new device is substantially equivalent to the predicate devices in this aspect. aspect.

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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 features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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: K041190

Trade/Device Name: A & I Power Wheelchair, PC - 401 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: April 30, 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 for about in the 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) I mo reter natification. 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 11 you active 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. Milhenson

6 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&I Power Wheelchair, PC-401

### 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 Usc

(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. K041190