WU'S POWERED WHEELCHAIR, MAMBO 36

K070655 · Wu'S Tech Co., Ltd. · ITI · Apr 2, 2007 · Physical Medicine

Device Facts

• Record ID: K070655
• Device Name: WU'S POWERED WHEELCHAIR, MAMBO 36
• Applicant: Wu'S Tech Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Apr 2, 2007
• 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

Mambo 36 is a battery-operated indoor/outdoor electric scooter/powered wheelchair. It features a four-wheeled base, seat, armrests, and front basket. The rider operates the device using hand controls located on the steering column. The device is designed for transport via disassembly and includes an onboard battery charger. It provides mobility for users restricted to a seated position. Clinical benefit is derived from restored independent mobility.

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 electrically powered wheelchairs and scooters.

Technological Characteristics

Battery-operated electric scooter/wheelchair. Four-wheeled base. Hand-controlled steering column. Materials meet strength and fatigue testing standards. Electronic systems (controller, motors, batteries) are UL certified. Disassemblable form factor.

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

• WU'S Powered Wheelchair MAMBO 36X (K050010)

Submission Summary (Full Text)

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K070655

APR - 2 2007

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

## 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:

December 26, 2007

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

WU'S POWERED WHEELCHAIR, MAMBO 36 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 WU'S Powered Wheelchair MAMBO 36 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, EN61000-3-2: 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 Powered Wheelchair MAMBO 36X (K050010)

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

## Summary for substantial equivalence comparison:

We can know from the above table that the intended use between the two devices is Mainframes of two devices are fixed. Mainframes materials of the two the same. devices all meet the strength and fatigue tests and they are similar for the material aspects. The overall dimensions are similar. The two devices use the same type of armrest, footplate and wheel lock, same seat size, same suspension of cross brace, same weight capabilities 130kgs, same maximum speed 6.4 km/hr, 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 recharge. Thus the same safety level for the two devices is assured.

The major differences exiting the two devices are the cruising range per charge and incline angle. This means the cruising range of the new device is 20-30 miles and the incline angle is 8 degrees, and the predicate device is 10~15 miles and 5 degrees for the incline angle. Certainly the real range depends on the practical environments, i.e., weight, surface, incline, and temperature. Thus 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wu's Tech Co., Ltd. % Republic of China Chinese-European Industrial Research Society Dr. Jen Ke-Min Official Correspondent No. 58, Fu-Chiun Street Hsin-Chu City, 30067, Taiwan Republic of China

APR - 2 2007

Re: K070655

Trade/Device Name: Wu's Power Wheelchair, Mambo 36 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 26, 2007 Received: March 9, 2007

Dear Dr. Ke-Min:

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, Or us and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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, l'isting 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 revire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition FFA 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. Jen Ke-Min

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 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/industry/support/index.html.

Sincerely yours,
Mark A. Mikus

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

510 (K) Number ( If Known ):____ K

Device Name: WU'S POWER WHEELCHAIR, MAMBO 36

Indications for Use:

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

Over-The-Counter Use AND/OR Prescription 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

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**510(k) Number**