The HOLI I scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Device Description

The HOLI I scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The HOLI I scooter is with a 130 kg (286 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 27 km (16.9 miles) with 32/36AH which maximum speed upto 9.5 km/hr (5.6 mph).

AI/ML Overview

The provided text describes the "HOLI I scooter" and its equivalence to a predicate device, focusing on non-clinical testing. It does not contain information about the acceptance criteria or a study proving device performance using human reader data, as generally understood in the context of AI/software medical devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines an equivalency claim based on compliance with established performance standards for wheelchairs, not "acceptance criteria" in the sense of a study's primary endpoints for a medical device's diagnostic output. The "reported device performance" is essentially that the device meets these standards.

Acceptance Criteria (Standard)	Reported Device Performance
ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999 (Static Stability)	Device meets this standard.
ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 (Static, Impact, and Fatigue Strengths)	Device meets this standard.
ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 (Electromagnetic Compatibility)	Device meets this standard.
CISPR 11-1990 (Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment)	Device meets this standard.
IEC 61000-4-2-1995 (EMC-Electrostatic Discharge Immunity Test (ESD))	Device meets this standard.
IEC 61000-4-3-1995 (EMC-RF Electromagnetic Field Immunity Test)	Device meets this standard.
California Bureau of Home Furnishings 116 (Flammability Standards)	Device meets this standard.

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

This information is not provided in the document. The testing described is for physical product standards (e.g., stability, strength, EMC) and would typically involve a small sample of the physical device rather than a "test set" of data as in software/AI. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not applicable and therefore not provided. The "ground truth" for compliance with these engineering standards is the outcome of the physical test itself (e.g., the device did not tip over, it withstood the impact, etc.), not expert interpretation of data.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical image interpretations or clinical outcomes, which is not the type of testing described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical scooter, not an AI or software device that assists human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

No, a standalone study in the context of an algorithm's performance was not done. The "studies" were non-clinical tests of the physical scooter's performance against engineering standards.

7. Type of Ground Truth Used:

The "ground truth" implicitly used is the objective outcome of the engineering and safety tests defined by the various ANSI/RESNA, ISO, IEC, CISPR, and California Bureau of Home Furnishings standards. This is not medical expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

This information is not applicable and therefore not provided. The development of a physical product like a scooter does not involve a "training set" in the context of AI/machine learning.

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

This information is not applicable and therefore not provided. There is no training set for this type of device. The design and manufacturing would be based on engineering principles and compliance with the relevant standards.

Summary

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Manufacture name: TUNG DENG ENTERPRISE CO., LTD.

KOSO 50 7 JUL 7 - 2005

510(k) Summary

Smartech Co., LTD.

HOLI I scooter

510(k) summary

Sponsor's information:

Phone: +886-4-23501100 Facsimile: +886-4-23504590 e-mail: cwl@tbnet.org.tw

Smartech Co., LTD.

Phone: +886-4-26814881 Facsimile: +886-4-26815211

Device

Date prepared: February 25, 2005

Proprietary and Manufacturer information:

Contact person: Irene Kuo, President

e-mail: lungi001@ms5.hinet.net

Trade name: HOLI I scooter

Regulation number: 890.3800

Product Code: 89INI Classification: Class II

Predicate devices

Common name: Electrical scooter

Cycling and Health Tech Industry R&D Center

No. 17, 37th Rd., Taichung Industry Park, Taichung, Taiwan

No. 3, Kung 10th Rd., Tachia Town, Taichung Hsien, Taiwan

Contact person: Dr. Chang Wan-Lan, Director of Testing Department

Name: Be-Mobile 4-Wheeled Electric Scooter, DK S500

Classification name: Motorized three-wheeled vehicle Medical specialty (Panel): Physical Medicine Device

7-1

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KOSOSO7

Intend use of device

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

Device description:

The HOLI I scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The HOLI I scooter is with a 130 kg (286 lbs) weight capacity.

The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat.

It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The scooter is powered by two 12 volt lead-acid DC batteries with 27 km (16.9 miles) with 32/36AH which maximum speed upto 9.5 km/hr (5.6 mph).

Substantial equivalence:

The HOLI I scooter is substantially equivalent to the Be-Mobile 4-Wheeled Electric Scooter, DK S500 (K033239) manufactured by TUNG DENG ENTERPRISE CO., LTD..

Analysis of comparison of design, function and feature of HOLI I scooter to TUNG DENG DK S500 (K033239), together with the results of compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended.

While 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

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K050507

they raise any new questions pertaining to safety or effectiveness. Therefore, Smartech believes that the HOLI I scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

Non-Clinical testing

HOLI I scooter has been tested to wheelchair standards. They include:

(1). ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999 Determination of static stability
(2). ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods
(3). ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters
(4). CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics - limits and methods of measurement
(5). IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD)
(6). IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test
(7). California Bureau of Home Furnishings 116 Flammability Standards.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

JUL 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chang Wan-Lan Cycling and Health Tech. Industry R & D Center Number 17, 37th Road Taichung Industry Park Taichung, China (Taiwan) 40768

Re: K050507

Trade/Device Name: HOLI I Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: June 9, 2005 Received: June 9, 2005

Dear Mr. Wan-Lan:

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 (2) __ 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 – Mr. Chang Wan-Lan

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 (240) 276-0120 . 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/industry/support/index.html.

Sincerely yours,

Stupt Rlurdu

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device descriptive information

3.1 Statement of indication for use

Statement of Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: HOLI I

Indications for Use:

The HOLI I scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Prescription Use _X Over-The-Counter Use (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 I of 1

Stupt Alurde
(Division' Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_ (050507

(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).