The Zip'r Mantis powered wheelchair is intended for an indoor/outdoor power wheelchair 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 Zip'r Mantis powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into three manageable components (seat set, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Zip'r Mantis powered wheelchair, based on the provided 510(k) summary:

This device is a physical product (a powered wheelchair), not an AI/software device. Therefore, the questions related to AI/software performance metrics, ground truth, expert adjudication, MRMC studies, and training/test set details are not applicable in this context. The study performed is engineering and safety testing against recognized standards.

Acceptance Criteria and Reported Device Performance

The Zip'r Mantis powered wheelchair's acceptance criteria are based on compliance with several international and national standards for wheelchairs. The study performed was a summary of non-clinical testing demonstrating this compliance.

Acceptance Criteria (Standard)	Reported Device Performance (Compliance)
ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999	Complied
ANSI/RESNA ANSI/RESTAT - NOT/20176-6-2001	Complied
ANSI/RESNA 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

Explanation of the Study and Why Other Information is Not Applicable:

The provided document is a 510(k) summary for a physical medical device (a powered wheelchair). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering and safety testing. It is not an AI/Software as a Medical Device (SaMD) submission.

Therefore, the following points are not applicable and cannot be answered from the provided text:

Sample size used for the test set and data provenance: This refers to data used for AI model evaluation. For a physical device, testing involves physical prototypes or production units against specified standards. The document doesn't detail the number of wheelchairs tested, but it does state they "complied with the requirements."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "Ground truth" and "experts" in this context typically refer to clinical or diagnostic interpretation for AI/software. For a wheelchair, ground truth is defined by the objective pass/fail criteria of the engineering standards.
Adjudication method for the test set: Not applicable to engineering compliance testing.
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: MRMC studies are specific to evaluating human reader performance with and without AI assistance in interpretation tasks. This is not relevant for a powered wheelchair.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm being evaluated in a "standalone" fashion.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" is defined by the objective, quantifiable requirements outlined in the cited engineering and safety standards.
The sample size for the training set: Not applicable, as there is no AI model requiring a training set.
How the ground truth for the training set was established: Not applicable, as there is no AI model requiring a training set.

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

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

OLT 4 2010

Trade name: Zip'r Mantis powered wheelchair

Common name: Powered wheelchair

Classification name: Powered wheelchair

Medical specialty (Panel): Physical Medicine Device

Regulation number: 890.3860

Product Code: ITI

Classification: Class II

Predicate devices

CWD01 (K062888) / EMG Technology Co. Ltd.

Zip'r PC (K072224) / Global FabTech Wheelchair (Shanghai) Co., Ltd.

Intend use of device

The Zip'r Mantis powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.

Device description

Summary of non-clinical testing

The Zip'r Mantis powered wheelchair complied with the requirements of ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999, ANSI/RESNA ANSI/RESTAT - NOT/20176-6-2001, ANSI/RESNA WC/Vo1.2 section

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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

: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.

Substantial equivalence:

The Zip'r Mantis powered wheelchair is substantially equivalent to the CWD01 (K062888) and Zip'r PC (K072224) manufactured by EMG Technology Co. Ltd. and Global FabTech Wheelchair (Shanghai) Co., Ltd., respectively.

There are minor differences in performance specifications of the powered wheelchairs, 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, Global FabTech Wheelchair (Shanghai) Co., Ltd. believes that the Zip'r Mantis powered wheelchair is substantially equivalent to legally marketed devices currently in commercial distribution.

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'r Mantis powered wheelchair is substantially equivalent to predicate devices as described herein.

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Image /page/2/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 image of an eagle.

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: K102355

Trade/Device Name: Zip'r Mantis powered wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 1, 2010 Received: September 1, 2010

0CT 4 2010

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. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for
Mark N. Melkerson

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): K102355

Device Name: Zip'r Mantis powered wheelchair

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 801 Subpart D) AND/OR (Part 21 CFR 807 Subpart C) (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

signature

ical, Orthopedie, Restorative Devices

510(k) Number: K102355

(Posted November 13, 2003)

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).