(97 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
JUSTWIN SCOOTER, JS-3013
The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "JUSTWIN SCOOTER, JS-3013". This document is a regulatory approval notice and does not contain information about acceptance criteria, device performance, study data, or clinical trials that would address the questions posed.
Therefore, I cannot provide the requested information based on the given text.
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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.
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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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
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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.
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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_
§ 890.3800 Motorized three-wheeled vehicle.
(a)
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.(b)
Classification. Class II (performance standards).