WU'S POWERED WHEELCHAIR, MAMBO 2

K052559 · Wu'S Tech Co., Ltd. · ITI · Sep 26, 2005 · Physical Medicine

Device Facts

• Record ID: K052559
• Device Name: WU'S POWERED WHEELCHAIR, MAMBO 2
• Applicant: Wu'S Tech Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Sep 26, 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 sitting position.

Device Story

MAMBO 2 is a battery-operated indoor/outdoor electric scooter; provides mobility to persons restricted to a seated position. Device features four-wheeled base, seat, armrests, and front basket. Rider operates device via hand controls on steering column. Device is foldable/disassemblable for transport; includes onboard battery charger. Healthcare provider/patient use; output is physical mobility. Benefits include increased independence for mobility-impaired users.

Clinical Evidence

Bench testing only. EMC testing performed per ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, and IEC61000-3-3: 1995. Mainframe materials verified via strength and fatigue testing.

Technological Characteristics

Battery-operated electric scooter; four-wheeled base. Control system: Penny & Giles. Components (recharger, batteries) UL certified. Foldable mainframe. Connectivity: None. Sterilization: N/A.

Indications for Use

Indicated for persons restricted to a sitting 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 3 (K030707)

Submission Summary (Full Text)

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Ko52559

SEP 26 2005

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

### દ 510(k) SUMMARY "

Submitter's Name: WU'S TECH CO., LTD. NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN)

Date summary prepared:

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

September 6, 2005

WU'S POWERED WHEELCHAIR, MAMBO 2 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 restricte to a seated position.

Description of the device:

The WU'S Powered Wheelchair MAMBO 2 is an indoor / outdoor electric scoote 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 3 (K030707)

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# WU'S TECH CO., LTD.

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

### C.2 COMPARISON SUMMARY

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

We can know from the above table that the intended use between the two devices is Mainframes of two devices are foldable. 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 used the same type of armrest and the same weight limit. Back upholstery material is also the same fabric. Besides the recharger, batteries, and these critical electrical components are also certified by UL. For the operator's safety aspect they are substantially equivalent.

The maximum speed for the new device is 3.5 mph and 4.0 mph for the predicate device. Lower speed means the new device shall more easily to meet the relevant requirements for the braking time, distance, and dynamic stability for safety considerations.

The major difference existing for new device is more agile and easy to fold for storage or transportation and the predicate device is for general use. The control systems for the two devices are different. It is Dynamic DL for the predicate device and Penny & Giles for the new device. Two of the control systems are all FDA-clearance. CThe safety and performance functions of two systems are assured and validated. They are substantially equivalent. Maximum range per charge is 16 km for the new device, and 40 km for the predicate device. - Certainly the real range depends on the practical environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.

Based on the above the information and the analysis, we know that the subject device and 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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## NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TA FAX: [phone] TEL: [phone] Homepage: www.wustech.com.tw | Email: [e-mail]

## Summary for substantial equivalence comparison:

The intended use between the two devices is the same. Mainframes materials of the two devices all meet the strength and fatigue tests and they are similar for the material aspects. The overall dimensions are similar. The two devices used the same type of armrest and the same weight limit. Back upholstery material is also the same fabric. Besides the recharger, batteries, and these critical electrical components are also certified by UL. For the operator's safety aspect they are substantially equivalent.

The major difference existing for new device is more agile and easy to fold for storage or transportation and the predicate device is for general use. The differences existing are control system, the size of seat, maximum speed, cruising range, and the incline degrees 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle or bird-like symbol with three curved lines representing its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the border of the circle.

Public Health Service

SEP 26 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ROC Chinese-European Industrial Research Society c/o Dr. Jen Ke-Min Wu's Tech Co., LTD No. 58, Fu-Chiun Street Hsin-Chu City, China (Taiwan) 300

Re: K052559

R052357
Trade/Device Name: WU'S POWERED WHEELCHAIR, MAMBO 2 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 6, 2005 Received: September 16, 2005

Dear Dr. Jen Ke-Min:

We have reviewed your Section 510(k) premarket notification of intent to market the device i we nave reviewed your Section 910(x) premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tuse stated in the encrosule) to regally manation to the Medical Device American be of the d. Food. Days commerce prior to May 20, 1770, the encenture with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarinians of the Act, T and Cosment Act (Act) that do not require approvince approvisions of the Act. The You may, increrore, market the act include requirements for annual registration, listing of general controls provisions of the 110 lise in a sainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device is classified (600 a0070) in. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to such additional controller 2. Title 21, Parts 800 to 898. In addition, FDA may be found in the Ooue of Peachasing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oc auvised that 1 Dri- 3 issuates of would in the requirements of the Act that IDA has made a dolorimiations administered by other Federal agencies. You must of any Federal Statutes and regulations and including, but not limited to: registration and listing (21 comply with an the rice srequirements, as and manufacturing practice requirements as set CFR Part 6077, adoming (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. Jen Ke-Min

This letter will allow you to begin marketing your device as described in your Section 510(k)
The are and the may of a lines of a line of a legical statish scrivelence of you This letter will anow you to begin hancemig your article equivalence of your device to a legally premarket notification. The PDA mining of backantal equi
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 If you desire specific advice for your ac not the collection of the regulation entitled, and the may abtain contact the Office of Complanes at (210) =i Ecation" (21CFR Part 807.97). You may obtain "Misbranding by relefence to premarket inclifical virtual the Act from the Division of Small other general information on your responsion.com at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its to the seconding http:/ Manufacturers, International and Oomsanhttp://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

2

Mark N. Melkerson Acting 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 POWERED WHEELCHAIR, MAMBO 2

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 Use _

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDI

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

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