WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR by WU'S TECH CO., LTD.

The WU'S 3-WHEELED SCOOTER WT-M3Jr is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

AI/ML Overview

The medical device in question is the "WU'S 3-Wheeled Scooter, WT-M3Jr", an electrical scooter intended for medical purposes to provide mobility to persons restricted to a seated position.

This is a 510(k) premarket notification, which means the device is seeking substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with established acceptance criteria. Therefore, the information provided focuses on the comparison to the predicate device and performance testing relevant to safety standards, rather than clinical performance metrics typical of AI/diagnostic devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this device type (electrical scooter), acceptance criteria are primarily related to safety and build quality, demonstrated through compliance with recognized standards and comparison to a predicate device. There aren't specific "performance metrics" in the clinical sense like sensitivity or specificity.

Acceptance Criteria (Demonstrated via)	Reported Device Performance
Safety and Electrical System Equivalence	"The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured."
Electromagnetic Compatibility (EMC)	"EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)" - Implies adherence to these standards for safety in electromagnetic environments.
Functional Equivalence (with improvements)	The new device (WT-M3Jr) is noted to be "more agile and easy to storage or transportation" compared to the predicate (WT-M3, K014119), which is for "general use". Differences in overall dimension, tire size, and weight are acknowledged but deemed not to affect safety. The overall appearance is also deemed not a safety aspect.
Substantial Equivalence to Predicate Device (WU'S 3-WHEELED NEO SCOOTER WT-M3 (K014119))	The FDA determined the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of clinical test sets for diagnostic accuracy. The "testing" here refers to engineering and safety compliance, likely involving one or a few units of the scooter for standard testing.
Data Provenance: The document does not specify the country of origin for the performance testing data beyond the manufacturer being in China (Taiwan). The testing is prospective for the specific device being submitted, following established engineering standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable as this is an electrical scooter, not an AI/diagnostic device requiring expert consensus for a clinical ground truth. The "ground truth" here is compliance with engineering standards as assessed by testing laboratories and regulatory bodies.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical evaluations, typically for AI or diagnostic devices.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks, which is not applicable to an electrical scooter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an electrical scooter and does not feature an algorithm or AI component that would be evaluated for standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is primarily compliance with recognized safety and performance standards (e.g., EMC standards, UL certification) and demonstrated substantial equivalence to a legally marketed predicate device. This is based on technical specifications and engineering tests, not clinical outcomes or pathology.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI and therefore does not have a "training set" in that context.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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K033032 1/

August 23, 2003

NOV 1 0 2003

NO. 225, YUAN-PIER S TEL: 886-5-5382105 Homepage: www.wustech.com.tw tis@ms45.hinet.net

510(k) SUMMARY " ર્દ

Submitter's Name: WU'S TECH CO., LTD.

NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN)

Tel: 88

Date summary prepared:

Device Name:

Proprietary Name:	WU'S 3-Wheeled Scooter, WT-M3Jr
Common or Usual Name:	Electrical Scooter
Classification Name:	Motor Three-Wheeled Vehicle, Class II, 21 CER 890 3800

Indications for Use:

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

Description of the device:

Performance Testing:

EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: WU'S 3-WHEELED NEO SCOOTER WT-M3 (K014119)

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K033032 2/2

NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHIN FAX: 886-5-53821 TEL: 886-5-5382105 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net

Summary for substantial equivalence comparison:

The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured. The major differences existing of the two 3-wheelled scooters are the different controller, and the new device, WT-M3Jr, is more agile and easy to storage or transportation and the predicate device, WT-M3, is for general use. Besides the overall dimension, the size of tires, and the weight are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle.

NOV 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WU'S Tech. Co., LTD C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K033032

Trade/Device Name: WU'S 3-Wheeled NEO Scooter, WT-M3Jr Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: October 16, 2003 Received: October 23, 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, 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), 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,

Miriam C. Provost

for 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 WIJ'S 3-WHEELED NEO SCOOTER, WT-M3Jr > 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

( Per 21 CFR 801.109 )

( Optional Format 1-2-96 )

Miriam C. Provost

510(k) Number K033032

।र ।

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).