The Be-Mobile 4-Wheeled Electric Scooter DK S600 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat. 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 provided text is a 510(k) summary for a medical device (Be-Mobile 4-Wheeled Electric Scooter, DK S600) seeking substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as an existing one, rather than presenting a performance study against predefined acceptance criteria for a novel medical device.

Therefore, many of the requested elements (like a table of acceptance criteria and reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or not detailed in this document.

However, I can extract information related to the performance testing that was conducted to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Reference)	Reported Device Performance & Finding
EMC Report:
ANSI / RESNA WC/Vol.2-1998	The submission states "all passed" by UL certification for electronic systems, implying compliance with safety standards.
CISPR 11: 1990
EN61000-3-2: 1995
IEC61000-3-3: 1995
Overall Safety Level (comparative to predicate)	The electronic systems between the two devices are the same and UL certified, ensuring the same safety level.

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

Sample Size: Not explicitly stated. The performance testing refers to standards (EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995). These are likely conducted on a small sample of the device itself (e.g., one or a few units) to verify compliance.
Data Provenance: The testing was conducted by TUNG KENG Enterprise Co., Ltd. (Taiwan) and confirmed by UL certification in the context of a 510(k) submission. It represents prospective testing of the device for compliance with relevant standards.

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

This information is not applicable to this type of regulatory submission. The "ground truth" here is compliance with established engineering and safety standards (e.g., EMC, RESNA). Certification bodies like UL (Underwriters Laboratories) are involved in verifying this compliance, but the number and specific qualifications of their individual experts are not detailed in this document.

4. Adjudication method for the test set

Not applicable. Performance is assessed against quantitative standards, not through expert consensus on qualitative data.

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 device is an electric scooter, not an AI-enabled diagnostic or assistive system for human readers.

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

Not applicable. This device is a mechanical and electronic mobility aid, not an algorithm.

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

The "ground truth" used for this device's performance testing is adherence to international and national engineering and safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) verified through testing and certification.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable.

Summary

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K633219 1/2

NOV 1 2 2003

TUNG KENG ENTERPRISE CO., LTD.

No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, Taiwan Tel: +886-4-25321000 Fax: +886-4-25325000 E-mail: dkcity@ms21.hinte.net

દર 510(k) SUMMARY "

Submitter's Name: TUNG KENG Enterprise Co., Ltd. No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, 427,Taiwan

Date summary prepared:

September 29, 2003

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

Be-Mobile 4-Wheeled Electric Scooter, DK S600

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, EN61000-3-2: 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 4-WHEELED NEO SCOOTER WT-L4 (K013763)

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K033219 2/2

Image /page/1/Picture/1 description: The image shows the text "DK CITY" in a stylized font. The letters "DK" are in a bold, sans-serif font, while the "C" is in a cursive font. The letters "ITY" are in a slanted, sans-serif font. The text is black and the background is white.

TUNG KENG ENTERPRISE CO., LTD No. 1, Lane 160, Sec. 2 Tan-Fu RD., Tan-Tzu Hsiang Taichung County, Taiwan Tel: +886-4-25321000 Fax: +886-4-25325000 E-mail: dkcity@ms21.hinte.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. 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 seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

NOV 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tung Keng Enterprise Co., Ltd. C/o Dr. Jen Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K033219

Trade/Device Name: Be-Mobile 4 Wheeled Electric Scooter, DK S600 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: September 29, 2003 Received: October 3, 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. Jen Ke-Min

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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Page 1 of 1

510 (K) NUMBER ( IF KNOW ): __ TBA DEVICE NAME: Be-Mobile 4-Wheeled Electric Scooter, DK S600

INDICATIONS FOR USE:

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

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number_ KO33219

( 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_

( Per 21 CFR 801.109 )

( Optional Format 1-2-96 )

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).