KYMCO ForU EQ35 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.

Device Description

The KYMCO ForU EQ35 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

AI/ML Overview

The provided text is a 510(k) summary for the KYMCO ForU EQ35 scooter, a motorized three-wheeled vehicle intended for disabled or elderly persons. The document focuses on establishing substantial equivalence to predicate devices, rather than detailed performance studies against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this document.

Here's an analysis of the available information:

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

This information is not provided in the document. The 510(k) summary emphasizes "Substantial equivalence" to predicate devices, noting "minor differences in performance specifications... these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." This implies that the device is deemed acceptable if its performance is comparable to the predicate devices and does not introduce new safety or effectiveness concerns, but specific quantitative acceptance criteria or a direct comparison table are not included.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The 510(k) summary primarily discusses the description of the device and its predicate devices, not specific test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. As this is a 510(k) for a mobility scooter, it's unlikely to involve expert-established ground truth in the same way a medical imaging AI would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

This information is not provided in the document. This type of study design is irrelevant for a mobility scooter.

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

This information is not provided in the document. As this is a mechanical device, the concept of "standalone algorithm performance" is not applicable.

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

This information is not provided in the document. Given the nature of the device (mobility scooter), "ground truth" would likely relate to objective performance metrics (e.g., speed, range, stability, turning radius) measured against product specifications or standards, rather than expert consensus on a diagnosis or pathology.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of what is available in the document regarding acceptance and substantial equivalence:

The document primarily states that the acceptance criteria for market clearance is "substantial equivalence" to legally marketed predicate devices.

The study that proves the device meets the acceptance criteria (i.e., substantial equivalence) is implicit in the 510(k) submission itself. The submission provides:

Predicate devices: AVANTICARE SA4022 (K051538) and LERADO CHINA LIMITED ForU EQ30 (K072630).
Intended use: Both the subject device and predicate devices are intended for indoor/outdoor transportation for disabled or elderly persons limited to a seated position.
Device description: The KYMCO ForU EQ35 scooter is described as a battery-operated indoor/outdoor transportation vehicle controlled by a tiller handle and a thumb-operated potentiometer throttle control lever. This aligns with the general description of such devices.
Comparison statement: The manufacturer asserts that "There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." This statement is the core of their argument for substantial equivalence.

While the document does not include a detailed study report with specific measurements, the FDA's clearance (AUG - 4 2008) indicates that the agency reviewed the information provided by KWANG YANG MOTOR CO., LTD. and determined that the KYMCO ForU EQ35 scooter is substantially equivalent to the predicate devices and thus meets the requirements for market clearance under the 510(k) pathway. This regulatory finding serves as the "proof" that the device meets the implicit acceptance criteria of not presenting new safety or effectiveness concerns compared to existing devices.

Summary

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K081980

AUG - 4 2008

KWANG YANG MOTOR CO., LTD.

No. 35. Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan TEL: +886-7-3822526 FAX: +886-7-3825834

510(k) Summary

Device

Trade name: KYMCO ForU EQ35 scooter Common name: Electrical scooter Classification name: Motorized three-wheeled vehicle Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3800 Product Code: 89INI Classification: Class II

Predicate devices

AVANTICARE SA4022 (K051538), LERADO CHINA LIMITED ForU EQ30 (K072630), KWANG YANG MOTOR CO. LTD.

Intend use of device

KYMCO ForU EQ35 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

Device description:

Substantial equivalence:

The KYMCO ForU EQ35 scooter is substantially equivalent to the AVANTICARE SA4022 (K051538) and ForU EQ30 (K072630) manufactured by LERADO CHINA LIMITED and KWANG YANG MOTOR CO. LTD., respectively.

There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, KWANG YANG MOTOR CO., LTD. believes that the KYMCO ForU EQ35 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Besteam Technology Inc. % Ms. Junnata Chang 14F-2 NO. 1 Lane 25 Zhuangjing Road Banqiao, China (Taiwan) 220

AUG - 4 2008

Re: K081980 Trade/Device Name: KYMCO ForU EQ35 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: July 04, 2008 Received: July 11, 2008

Dear Ms. Chang:

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 - Ms. Junnata Chang

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

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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Statement of Indications for Use

510(k) Number (if known): __

Device Name: KYMCO ForU EQ35

Indications for Use:

To provide mobility to disabled or elderly persons limited to a seated position.

Prescription Use _ Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Mark A. Wilkerson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices KO8

510(k) Number

(Posted November 13, 2003)

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).