(220 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Not Found
This document is a 510(k) premarket notification approval letter for a medical device called "Wu's 3-Wheeled Neo Scooter, WT-M3". It does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on the FDA's regulatory decision regarding the substantial equivalence of the device to a predicate device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, arranged in a stacked formation. To the left of the profiles, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2002
Wu's Tech Company, LTD. Ke-Min Jen, Ph.D. c/o Roc Chinese-European Industrial Research Soc. No. 58. Fu-Chiun Street Nsin-Chu City, China (Taiwan)
Re: K014119
Trade Name: Wu's 3-Wheeled Neo Scooter, WT-M3 Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: July 4, 2002 Received: July 10, 2002
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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 vours.
Mark N. Mulkerson
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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NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) FAX: 886-5-5382191 TEL: 886-5-5382105 Email: wustis@ms45.hinet.net Homepage: www.wustecli.com.tw
B.1 INTENDED USE
The intended uses for the subject device and the predicate device are the same and it is
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
le Mark N. Milleson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K014119 510(k) Number -
N/A