BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200

K033240 · Tung Keng Enterprise Co., Ltd. · INI · Dec 18, 2003 · Physical Medicine

Device Facts

• Record ID: K033240
• Device Name: BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200
• Applicant: Tung Keng Enterprise Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Dec 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Be-Mobile DK S200 is a battery-operated, 3-wheeled electric scooter for indoor/outdoor use. Rider controls movement via hand controls on steering column. Device features seat and base; disassembles for transport; includes onboard battery charger. Used by patients with mobility restrictions. Provides mobility benefit by allowing independent navigation.

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

3-wheeled electric scooter; battery-operated; hand-controlled steering column; disassemblable frame. Safety testing per ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3. Upholstery passed resistance ignition testing (SGS).

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

• J.D. 3-wheeled SCOOTER ES-350 (K022518)

Submission Summary (Full Text)

{0}------------------------------------------------

### TUNG KENG ENTERPRISE No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang ichung County, Taiwan [phone] Fax: [phone] -mail: [e-mail]

#### દ્ધ 510(k) SUMMARY "

Submitter's Name: TUNG KENG Enterprise Co., Ltd. No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, 427,Taiwan

Date summary prepared:

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

Be-Mobile 3-wheeled Electric Scooter, DK S200 Electrical Scooter Motor Three-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 Be-Mobile 3-wheeled Electric Scooter DK S200 is an indoor / outdoor electric scooter that is battery operated. It has a base with 3-wheeled with a seat. 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: J.D. 3-wheeled SCOOTER ES-350 (K022518)

September 29, 2003

{1}------------------------------------------------

#

UNG KENG ENTERPRISE CO 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang chung County, Taiwan [phone] Fax: [phone] 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. 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 major differences existing of the two 3-wheelled scooters are different overall dimensions, and the dimensions for the new device are smaller than those of the predicate device. Thus the new device needs smaller the overall dimension, weight limit, and the scooter weights are differences between the two devices. The new device, DK S200, of the smaller dimensions can be fitted into most of the ordinary car trunk, and this is NOT related to the safe aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

{2}------------------------------------------------

## DEC 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tung Keng Enterprise Co., Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K033240

Trade/Device Name: Be-Mobile 3 Wheeled Electric Scooter, DK S200 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: II Product Code: INI Dated: November 18, 2003 Received: November 25, 2003

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, 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.

{3}------------------------------------------------

Page 2 - Dr. Ke - Min Jen

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-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

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

{4}------------------------------------------------

Page__________________________________________________________________________________________________________________________________________________________________________

# 510 (K) NUMBER ( IF KNOW ): _ K 033240

DEVICE NAME: Be-Mobile 3-Wheeled Electric Scooter, DK S200

INDICATIONS FOR USE:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over - The - Counter - Use V AND/OR

(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 )

** Restorative Devices