WU'S 4-WHEELED SCOOTER, WT-L4JR by WU'S TECH CO., LTD.

The WU'S 4-WHEELED SCOOTER WT-L4Jr 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

This document describes a mobility scooter, the WU'S 4-Wheeled Scooter, WT-L4Jr, and its substantial equivalence to a predicate device. The information provided does not pertain to an AI/ML powered medical device, therefore, many of the requested criteria are not applicable.

Here's an analysis of the provided information in the context of your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Predicate Device Equivalence	To be substantially equivalent to the legally marketed predicate device (WU'S 4-WHEELED NEO SCOOTER WT-L4 (K013763)). This implies similar safety and effectiveness.	The electronic systems between the two devices are the same and UL certified (electronic controller, batteries, recharge). The new device (WT-L4Jr) is more agile and easy to store/transport, while the predicate (WT-L4) is for general use. Differences in overall dimension, tire size, and weight are noted as "not safety aspect."
Performance Testing (Safety)	Conformance to relevant safety and performance standards for electrically powered wheelchairs and scooters.	EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-4-2: 1995, IEC61000-4-3: 1995 standards were used as references for performance testing. (The report states these were passed, but specific results are not detailed).
Indications for Use	Intended for medical purposes to provide mobility to persons restricted to a seated position.	The new device also meets this indication.

2. Sample size used for the test set and the data provenance

Not applicable. This device is a physical mobility scooter, not an AI/ML algorithm that uses a test set of data. The "testing" refers to physical product testing for safety and performance standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of AI/ML, refers to labels for datasets. For a physical product, "ground truth" would be established through engineering specifications, safety standards, and performance testing, likely conducted by qualified engineers and technicians, not experts establishing diagnostic labels.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the AI/ML sense, and thus no adjudication method for it.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this type of device, the "ground truth" for safety and performance would be established by:

Engineering Specifications: Design documents detailing materials, dimensions, electrical components, and mechanical functionality.
Safety Standards: Compliance with recognized national and international standards for electrically powered mobility devices (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-4-2, IEC61000-4-3).
Performance Metrics: Measured values for aspects like speed, braking distance, turning radius, battery life, stability, and electromagnetic compatibility.
Predicate Device Characteristics: The performance and safety profile of the legally marketed predicate device (WU'S 4-WHEELED NEO SCOOTER WT-L4) serves as a benchmark for equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set.

Summary

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NOV 1 2 2003

032617 1
O. IMM

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

46 510(k) SUMMARY "

Submitter's Name: WU'S TECH CO., LTD. NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) Tel: 88 Date summary prepared: August 19, 2003 Device Name: Proprietary Name: WU'S 4-Wheeled Scooter, WT-L4Jr Common or Usual Name: Electrical Scooter Classification Name: Motor Three-Wheeled Vehicle, Class II, 21 CFR 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, EN61000-4-2: 1995, IEC61000-4-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: WU'S 4-WHEELED NEO SCOOTER WT-L4 (K013763)

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K032617 2/2

NO. 225, YUAN-PIER ST., HSIN CHU CITY, C TEL: 886-5-5382105 FAX: 886-5-5382191 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 4-wheelled scooters are the different controller, and the new device. WT-L4Jr, is more agile and easy to storage or transportation and the predicate device. WT-L4, 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2003

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: K032617

Trade/Device Name: WU'S 4-Wheeled Scooter, WT-L4Jr Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: October 3, 2003 Received: October 20, 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

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: WU'S 4-WHEELED SCOOTER, WT-L4Jr

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 _____________________________________________________________________________________________________________________________________________________________

Over - The - Counter - Use J

( Per 21 CFR 801.109 )

( Optional Format 1-2-96 )

Miriam C. Provost

General, Restorative and Neurological Devices

510(k) Number K032617

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).