WU'S 3-WHEELED NEO SCOOTER, WT-T3D by WU'S TECH CO., LTD.

This document is a 510(k) clearance letter from the FDA for a medical device called "WU'S 3-Wheeled NEO Scooter, WT-T3D". It's a regulatory document indicating that the device has been found substantially equivalent to a predicate device, not a study report or clinical trial summary.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in the provided text.

The document primarily focuses on:

Device Name: WU'S 3-Wheeled NEO Scooter, WT-T3D
Regulation Number: 21 CFR 890.3800
Regulation Name: Motorized three-wheeled vehicle
Regulatory Class: II
Product Code: INI
Indications for Use: "The device is intended for medical purposes to provide mobility to persons restricted to a seated position."
Regulatory Conclusion: Substantial equivalence to a legally marketed predicate device, allowing the device to be marketed.
Usage: Over-The Counter Use.

Without a separate study report or clinical data submitted as part of the 510(k) application, it's impossible to provide the detailed information requested in the prompt. This document only confirms regulatory clearance, not the specifics of performance testing.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 2003

WU'S 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: K032488

Trade/Device Name: WU'S 3 - Wheeled NEO Scooter, WT - T3D Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vchicle 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 we nave teviewed your becaren b r (s) personalially equivalent (for the indications felerenced above and nave decembined his marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device American Continents. Or to connineres provise to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). alla Cosmette Ace (1 tot) market the device, subject to the general controls provisions of the Act. The I ou may, dicierore, market include requirements for annual registration, listing of general controlly provision 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 If your device is etassined (600 world). 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 docs not mcan I lease of advised that I Dr. Oradon that your device complies with other requirements of the Act that I DA has made a assessmantly other Federal agencies. You must or any I ederal statutes and survey including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It Fart 6077, laboring (21 CFR Part 820); and if applicable, the clectronic form in the quality by seems (Sections 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 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). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. 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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Page__________________________________________________________________________________________________________________________________________________________________________

510 (K) NUMBER ( IF KNOWN ): TBA DEVICE NAME: WU'S 3-WHEELED NEO SCOOTER, WT-T3D

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 ✓
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(Per 21 CFR 801.109) (Optional Format 1-2-96)

for

(Division Signature)

Division of General Restorative

and Neurological Devices

510(k) Number	K032488
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Regulation Number and Section

§ 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).