ZIP'R MANTIS POWERED WHEELCHAIR

K102355 · Global Fabtech Wheelchair (Shanghai) Co., Ltd. · ITI · Oct 4, 2010 · Physical Medicine

Device Facts

• Record ID: K102355
• Device Name: ZIP'R MANTIS POWERED WHEELCHAIR
• Applicant: Global Fabtech Wheelchair (Shanghai) Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Oct 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Battery-operated indoor/outdoor powered wheelchair; provides mobility for disabled or elderly persons limited to a seated position. Device features modular design, breaking down into three components: seat set, body frame with motors, and battery pack; facilitates transport via bus or train. Operated by user via integrated controls. Output is physical mobility; assists user in navigating indoor and outdoor environments. Benefits include increased independence and portability for travel.

Clinical Evidence

No clinical data. Bench testing only, including compliance with ANSI/RESNA WC/Vol.1 section 1-1998/ISO7176-1-1999, ANSI/RESNA WC/Vol.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.

Technological Characteristics

Battery-powered electric wheelchair; modular design (seat, frame, battery). Complies with ANSI/RESNA and ISO 7176 series standards for powered wheelchairs. Electromagnetic compatibility per IEC 61000 and CISPR 11. Flammability compliance per California Bureau of Home Furnishings 117.

Indications for Use

Indicated for disabled or elderly persons limited to a seated position requiring mobility assistance.

Regulatory Classification

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.

Predicate Devices

• CWD01 (K062888)
• Zip'r PC (K072224)

Submission Summary (Full Text)

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# Global-FabTech-Wheelchair-(Shanghai) Co., Ltd.

No. 318, TianFu Rd., Jiuting Songjiang, Shanghai, 201615, China FAX: [phone] TEL: [phone]

## 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

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.

## 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: [phone] FAX: [phone]

: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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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 [phone] or [phone] 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)