JUSTWIN SCOOTER, JS-3013

K032643 · Joy Ride Tech Co., Ltd. · INI · Dec 2, 2003 · Physical Medicine

Device Facts

• Record ID: K032643
• Device Name: JUSTWIN SCOOTER, JS-3013
• Applicant: Joy Ride Tech Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Dec 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• 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

The JUSTWIN SCOOTER, JS-3013 is a motorized three-wheeled vehicle designed to provide mobility to individuals restricted to a seated position. It functions as a personal mobility aid for use by patients. The device operates via an electric motor to transport the user. It is intended for over-the-counter use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized three-wheeled vehicle; electric power source; class II device; product code INI.

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.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 2003

Joy Ride Tech. Co., Ltd. C/o Ke-Min Jen, Ph.D. ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K032643

Trade/Device Name: JUSTWIN SCOOTER, JS-3013 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-whecled vehicle Regulatory Class: II Product Code: INI Dated: October 31, 2003 Received: November 10, 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 for abound in 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, de nees that have been require approval of a premarket approval 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 that I Dr Has matutes and regulations administered by other Federal agencies. You must or any I 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 – Ke-Min Jen, Ph.D.

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 premained 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 11 you atent 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 other golleral mitotimational 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,

Mark N. 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

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

Page_1__of_1_

510 (K) NUMBER ( IF KNOWN ): TBA DEVICE NAME: ___JUSTWIN SCOOTER, JS-3013

INDICATIONS FOR USE:

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

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

Concurrence of CDRH, office of Device Evaluation (ODE )

Prescription Use OR Over - The - Counter - Use v ( Per 21 CFR 801.109 ) ( Optional Format 1-2-96 ) AS 710(k) Number_