WU'S POWERED WHEELCHAIR, MAMBO 36X

K050010 · Wu'S Tech Co., Ltd. · ITI · Feb 11, 2005 · Physical Medicine

Device Facts

• Record ID: K050010
• Device Name: WU'S POWERED WHEELCHAIR, MAMBO 36X
• Applicant: Wu'S Tech Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Feb 11, 2005
• 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

Battery-operated indoor/outdoor electric scooter; four-wheeled base with seat, armrests, and front basket. Rider operates device via hand controls on steering column. Disassemblable for transport; includes onboard battery charger. Used by patients with mobility restrictions to navigate indoor/outdoor environments. Output is physical mobility provided by electric propulsion. Healthcare providers do not operate the device; it is intended for patient use.

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 powered wheelchairs and chargers.

Technological Characteristics

Battery-operated electric scooter; four-wheeled base. Materials meet strength and fatigue testing standards. Electronic controller, batteries, and charger are UL certified. Connectivity: None. Sterilization: N/A.

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

• TEH LIN JUPITER Powered Wheelchair TL-320 (K022697)

Submission Summary (Full Text)

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ITD K0500

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

## FEB 1 1 2005

#### 66 510(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:

December 30, 2004

- Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

WU'S POWERED WHEELCHAIR, MAMBO 36X 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 36X 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: TEH LIN JUPITER Powered Wheelchair TL-320 (K022697)

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

### Summary for substantial equivalence comparison:

The intended use between the two devices is the same. Mainframes of two devices are foldable. Mainframes materials of the two devices all meet the strength and fatigue tests and they are similar for the material aspects. The suspension of cross brace is the same. The two devices used the same type of armrest. Back upholstery material is also the same fabric. Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, Thus the same safety level for the two devices is assured. batteries, and recharge.

The major differences existing are the overall dimension, the size of seat, weight limit, maximum speed, cruising range, and the incline degrees is 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo. The logo is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 11 2005

WU's Tech. Co., L.T.D. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial No. 58, Fu- Chiun Street Hsin-Chu City China (Taiwan) ROC 300

Re: K050010

Trade/Device Name: WU's Power Wheelchair, Mambo 36X Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: January 31, 2005 Received: February 3, 2005

Dear Dr. Ke-Min Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for too bearing 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 r ou may, dicterere, mains of the Act include requirements for annual registration, listing of general controls proficturing 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 n may of basjon to back 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 that I Dr Hoal statutes and regulations administered by other Federal agencies. You must or any I oderal bather and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth 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 his icher will anow you to ough finding of substantial equivalence of your device to a legally prematics notification. " " 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 If you desire spoolite acrise is [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 other general mionnaational 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. Millman

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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# Indications for Use

510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________

Device Name: WU'S POWER WHEELCHAIR, MAMBO 36X

Indications for Use:

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

AND/OR Over-The-Counter Use Prescription Use _ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(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 K030010