Zip'r4 and Zip'r4 Xtra scooter are intended for the indoor/outdoor electrical scooter that provide 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 Zip'r4 and Zip'r4 Xtra scooter are the indoor/outdoor electrical scooter. The design of the scooters is basically similar to other electrical scooters that are already on the market. By providing the electrical scooter that breaks down into three manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.

The Zip'r4 and Zip'r4 Xtra scooters are with a 113 kg (250 Ibs) weight capacity. They are basic conventional rear wheel drive, rigid frame vehicle that are battery powered. They consist primarily of a welded steel frame, lighting system, a sealed powered. Incor (155W, DC24V) drive system, electromagnetic braking system, electric motor controller (PG S-Drive 45A) and two batteries with an off-board battery charger (2A). They are powered by two 12 volt lead-acid DC batteries with 16 km (10 miles) with 12 AH which maximum speed upto 6.8 km/hr (4.25 mph).

AI/ML Overview

The provided text describes the regulatory submission for the Zip'r4 and Zip'r4 Xtra scooters and their substantial equivalence to a predicate device. It primarily focuses on compliance with existing standards for motorized wheelchairs and the administrative process of 510(k) clearance.

Unfortunately, the document does not contain the detailed information necessary to answer all the questions regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way one might describe for a software or AI/ML-based medical device.

The context of this document is a 510(k) submission for a physical medical device (electrical scooter), not an AI/ML diagnostic tool. Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable or not provided.

However, I can extract the information related to the device's compliance with established standards, which serve as its "acceptance criteria" in this context.

Here's the breakdown of what is available from the provided text:

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

Acceptance Criteria (Standard / Requirement)	Reported Device Performance (Compliance)
ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999	Complied
ANSI/RESNA WC/Vo1.1 section 6-1998 / ISO7176-6-2001	Complied
ANSVRESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003	Complied
IEC 61000-4-2-2001	Complied
IEC 61000-4-3-2008	Complied
CISPR 11: 2004+A2: 2006	Complied
California Bureau of Home Furnishings 117 Flammability Standards	Complied

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

Sample Size: Not specified. Testing likely involved a representative number of units to demonstrate compliance with the listed standards, but the exact count is not detailed.
Data Provenance: Not specified, but Global FabTech Wheelchair (Shanghai) Co., Ltd. is based in Shanghai, China, and Taichung, China (Taiwan). The testing was for international (ISO/IEC), US (ANSI/RESNA), and California standards, implying testing was conducted to meet these specific regulations. The nature of the testing for physical device standards implies prospective testing of manufactured units rather than retrospective data analysis.

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)

Not applicable to this type of device. "Ground truth" in the context of physical medical devices typically refers to measured performance against established engineering and safety standards, usually conducted by certified testing laboratories, not medical experts establishing diagnostic ground truth.

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

Not applicable. This concept is relevant for expert review of medical images or data, not for testing the mechanical and electrical specifications of a mobility scooter.

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 for AI/ML diagnostic tools, not for a motorized scooter.

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

Not applicable, as this is not an algorithm-based device.

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

For this device, the "ground truth" for the test results (compliance with standards) is based on objective measurements and assessments against the specifications outlined in the referenced ANSI/RESNA, ISO, IEC, CISPR, and California Flammability standards, performed by qualified testing methods and equipment.

8. The sample size for the training set

Not applicable; this is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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Global FabTech Wheelchair (Shanghai) Co., Ltd.

No. 318, TianFu Rd., Jiuting Songjiang, Shanghai, 201615, China FAX: +86-21- 6763-2309 TEL: +86-21- 6763-2308

510(k) Summary

K102361

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date of summary was prepared: July 30, 2010

Device

. . .

DCT 4 2010

Trade name: Zip'r4 / Zip'r4 Xtra scooter

Common name: Electrical scooter

Classification name: Motorized three-wheeled vehicle

Medical specialty (Panel): Physical Medicine Device

Regulation number: 890.3800

Product Code: INI

Classification: Class II

Predicate devices

KYMCO ForU EQ 20 (K082901) / KWANG YANG MOTOR CO. LTD.

Intend use of device

Zip'r4 and Zip'r4 Xtra scooter are intended for the indoor/outdoor electrical scooter that provide transportation for disabled or elderly persons limited to a seated position.

Device description:

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Global FabTech Wheelchair (Shanghai) Co., Ltd.

No. 318, TianFu Rd., Jiuting Songjiang, Shanghai, 201615, China TEL: +86-21- 6763-2308 FAX: +86-21- 6763-2309

Summary of non-clinical testing

| The Zip'r4 and Zip'r4 Xtra scooter complied with the requirements of ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999, ANSI/RESNA WC/Vo1.1 section 6-1998 / ISO7176-6-2001, ANSVRESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003, IEC 61000-4-2-2001, IEC 61000-4-3-2008, CISPR 11: 2004+A2: 2006, and California Bureau of Home Furnishings 117 Flammability Standards.

Statement of substantial equivalence

The Zip'r4 and Zip'r4 Xtra scooter are substantially equivalent to the KYMCO ForU EQ 20 (K082901) manufactured by KWANG YANG MOTOR CO. LTD.. There are minor differences in performance specifications of the electrical 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.

Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Global FabTech Wheelchair (Shanghai) Co., Ltd. concludes that, Zip'r4 and Zip'r4 Xtra scooter are substantially equivalent to predicate devices as described herein.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Global FabTech Wheelchair (Shanghai) Co., Ltd. % Ms. Junnata Chang 16F-2 (16A), No. 462, Sec. 2, ChongDe Road, Beitun District Taichung, China (Taiwan) 406

Re: K102361

Trade/Device Name: Zip'r4 and Zip'r4 Xtra scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 1, 2010 Received: September 1, 2010

4 2017

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Junnata Chang

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for Thomas Collins

Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative 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): __K102361

Device Name: Zip'r4 and Zip'r4 Xtra scooter

Indications for Use:

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

Over-The-Counter Use __ X Prescription 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

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Division of Surgical, Orthropedic, and Restorative Devices

510(k) Number K102361

(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).