(134 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Wu's 3-Wheeled Neo Scooter, WT-L3
I am sorry, but based on the provided document, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a "Wu's 3-Wheeled Neo Scooter, WT-L3," which is classified as a "Motorized, three-wheeled vehicle."
This document does not contain any information about:
- Acceptance criteria or device performance for medical imaging or AI analysis.
- Sample sizes for test sets or training sets.
- Data provenance, expert qualifications, or ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or standalone algorithm performance.
The letter simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices for providing mobility to persons restricted to a seated position. It pertains to a physical medical device, not a software or AI-driven diagnostic tool.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
JAN 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wu's Tech Company, LTD. Ke-Min Jen, Ph.D. c/o Roc Chinese-European Industrial Research Society No.58, Fu-Chiun St. Hsin-Chu City, Taiwan
Re: K023040
Trade/Device Name: Wu's 3-Wheeled Neo Scooter, WT-L3 Regulation Number: 890.3800 Regulation Name: Motorized, three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: December 31, 2002 Received: January 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. Ilsting 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
{1}------------------------------------------------
Page 2 - Dr. Ke-Min Jen
(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. 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 (301) 594-4659. 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 yours,
Mark N. Melkerson
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 WU'S 3-WHEELED NEO SCOQTER, WT-L3 DEVICE NAME:
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 7
( Per 21 CFR 801.109 )
( Optional Format 1-2-96 )
Mark n Mellem
K 023040
48007-117 Oceral, Restorative and Nearorogical Devices
§ 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).