The WU'S 3-WHEELED NEO SCOOTER WT-T3E is an indoor / outdoor electric scooter that is battery operated. It has a base with three-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 document provided describes a 510(k) premarket notification for a medical device, the WU'S 3-WHEELED NEO SCOOTER WT-T3E. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria as you might see for novel medical devices. Therefore, much of the requested information regarding detailed performance studies, sample sizes, expert ground truth, MRMC studies, and training set information is not typically found or required in a 510(k) filing that relies on substantial equivalence.

Based on the provided information, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (WU'S WT-T3E)
Safety - Electrical	EMC Compliance (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-4-2: 1995, IEC61000-4-3: 1995)	Passed EMC Report; Electronic systems are UL certified (controller, batteries, recharge).
Safety - Fire Resistance	Resistance ignition test for back upholstery	Passed resistance ignition test by SGS for back upholstery.
Performance - Intended Use	Provides mobility to persons restricted to a seated position.	Same intended use as predicate device WT-T3D.
Performance - Weight Limit	Specific weight limit (details not provided)	Same weight limit as predicate device WT-T3D.
Performance - Cruising Range	Specific cruising range (details not provided)	Same cruising range as predicate device WT-T3D.
Performance - Maximum Speed	Specific maximum speed (details not provided)	Same maximum speed as predicate device WT-T3D.
Stability/Structure - Safety Climbing Angle	Specific safety climbing angle (details not provided)	Same safety climbing angle as predicate device WT-T3D.
Durability - Warranty Period	Specific warranty period (details not provided)	Same warranty period as predicate device WT-T3D.

Study that Proves Device Meets Acceptance Criteria:

The primary study approach described is a comparison to a legally marketed predicate device (WU'S 3-WHEELED NEO SCOOTER WT-T3D, K032488) to establish "substantial equivalence." The sponsor performed performance testing for EMC and fire resistance, but the overall demonstration of equivalence relies on the known safety and performance profile of the predicate.

Missing Information (Not typically provided in a 510(k) for substantial equivalence):

The following information is generally not provided or required for a 510(k) where substantial equivalence is demonstrated primarily through comparison to a predicate device, especially one involving a physical product like a scooter rather than an AI/software device.

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing was conducted for EMC and fire resistance, but these are typically engineering tests on the device itself, not a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This concept is relevant for AI devices where diagnostic accuracy is assessed against expert consensus. For a physical device like a scooter, "ground truth" would be objective measurements of physical properties and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 type of study is for AI-assisted diagnostic tools.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance testing, the ground truth would be the objective measurements and adherence to the specified technical standards (e.g., EMC standards, fire resistance standards). For the comparison to the predicate, the "ground truth" is the established safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set: Not applicable. This concept is for AI/machine learning models.

9. How the ground truth for the training set was established: Not applicable.

Summary

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WUS TECH CO.,LTD. K062790

NO. 225, YUAN-PIER ST., HSIN C TEL: 886-3-5382105 FAX . 886-3-5382 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net

510(k) SUMMARY "

OCT 1 1 2006

Submitter's Name: WU'S TECH CO., LTD. NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN)

દ્ધ

Date summary prepared:

September 12, 2006

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

WU'S 3-WHEELED NEO SCOOTER WT-T3E Electrical Scooter 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 3-WHEELED NEO SCOOTER WT-T3D (K032488)

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NO. 225, YUAN-PIER ST., HSIN CHU CITY, CHINA (TAIWAN) TEL: 886-3-5382105 FAX: 886-3-5382191 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net

Summary for substantial equivalence comparison:

The intended uses, weight limit, cruising range, maximum speed, back upholstery, safety climbing angle, and warranty period between the new device WT-T3E and the predicate device WT-T3D are all the same. Especially the electronic systems between two devices are all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Thus the same safety level for the two devices is assured.

The major difference existing for new device is the-overall dimension, the size of tires, and the weight are differences between the two devices. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.

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

C.2 COMPARISON SUMMARY

( We place the related information for the predicate device in the following pages. )

The intended uses, weight limit, cruising range, maximum speed, back upholstery, safety climbing angle, and warranty period between the new device WT-T3E and the predicate device WT-T3D are all the same. Especially the electronic systems between two devices are all passed by the UL certificated, for instance the electronic controller, batteries and recharge.. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Thus the same safety level for the two devices is assured.

The major difference existing for new device is the overall dimension, the size of tires, and the weight are differences between the two devices. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.

Based on the above the information and the analysis, we know that the subject device and the predicate devices have the same intended use, the same technological aspects and only minor dimensions or data differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of several curved lines that create the shape of the bird's head, body, and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT I 1 2006

Wu's Tech Co., Ltd. % Dr. Jen Ke-Min ROC Chinese-European Industrial Research Society No. 225, Yuan-Pier Street, Hsin Chu City, China (Taiwan)

Re: K062790

Trade/Device Name: WU's 3-Wheeled Neo Scooter, WT-T3E Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 12, 2006 Received: September 18, 2006

Dear Dr. Ke-Min:

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. Jen Ke-Min

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin makemily of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalias and thu premarket nouffication. The I DA miding of backands of 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 If you desire specific advice for your ac not an early of a can and the regulation entitled, Contact the Office of Comphance at (216) 276 Part 807.97). You may obtain "Misoranding by reletence to premarket noutheansh (= ) = = = = other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its him becamers/spancer/inde Manufacturers, International and Consulter Prosition of Consulters of Carbindustry/support/index.html.

Sincerely yours,

Karbow Budny

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510 (K) Number ( If Known ):___ K

Device Name: WU'S 3-WHEELED NEO SCOOTER, WT-T3E

Indications for Use:

Comments of the states

the complex of the contribution of the

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

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Barbara buchin

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K062790

Page 1 of 1

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).