BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320

K033241 · Tung Keng Enterprise Co., Ltd. · INI · Nov 10, 2003 · Physical Medicine

Device Facts

• Record ID: K033241
• Device Name: BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320
• Applicant: Tung Keng Enterprise Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Nov 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

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

Device Story

Be-Mobile DK S320 is a 3-wheeled, battery-operated electric scooter for indoor/outdoor use. Rider operates device via hand controls on steering column. Device is collapsible for transport; includes onboard battery charger. Provides mobility for individuals restricted to seated position. Substantial equivalence established via comparison to predicate scooter; differences in controller (Dynamic Rhino DS72k vs. Curtis PMC), dimensions, tire size, and weight do not impact safety.

Clinical Evidence

Bench testing only. Compliance with EMC standards 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; Dynamic Rhino DS72k electronic controller; onboard battery charger. Tested to ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, and IEC61000-3-3 standards.

Indications for Use

Indicated for persons restricted to a seated 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

• WU'S 3-wheeled NEO SCOOTER WT-L3 (K023040)

Submission Summary (Full Text)

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

K033241 1/2

September 29, 2003

Image /page/0/Picture/1 description: The image shows the text "DK CITY" in a stylized font. The letters "DK" are in a bold, sans-serif font, while "CITY" is in a cursive font. There is a design element between "DK" and "CITY" that resembles angled brackets. The text is black against a white background.

TUNG KENG ENTERPRISE CO., LTD. No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, Taiwan Tel: [phone] Fax: [phone] E-mail: [e-mail]

NOV 1 0 2003

## 6 é 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 S320

Electrical Scooter Motor Three-Wheeled Venicle, 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 S320 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 enboard 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 3-wheelED NEO SCOOTER WT-L3 (K023040)

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

K033241 2/2

## DK(C/T)

TUNG KENG ENTERPRISE CO., LTD. No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, Taiwan Tel: [phone] Fax: [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 3-wheelled scooters are the different controller. That means the new device, DK S320, use Dynamic Rhino DS72k controller, and the predicate device, WT-L3, use Curtis PMC controller. Besides the overall dimension, the size of tires, and the weight are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with three parallel lines above them, resembling flowing hair or a symbolic representation of health and human services.

NOV 1 0 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: K033241

Trade/Device Name: Be-Mobile 4 Wheeled Electric Scooter, DK S320 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: September 29, 2003 Received: October 6, 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. Iisting 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

iriam C. Provost

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 1 of 1

510 (K) NUMBER ( IF KNOW ): _ TBA

DEVICE NAME: Be-Mobile 3-Wheeled Electric Scooter, DK S320

INDICATIONS FOR USE:

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

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

Concurrence of CDRH, office of Device Evaluation (ODE )

OR

Prescription Use

Over -- The -- Counter -- Use

( Per 21 CFR 801.109 )

( Optional Format 1-2-96 )

Miriam C. Provost
(Division Sign Off)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number Ko33241

、その後の時間を行って、不用の行動になっていると、

FI