WHEELCHAIR, MODEL 8500-II

K043332 · Cycling and Health Tech. Industry R&D Center · IOR · Dec 13, 2004 · Physical Medicine

Device Facts

• Record ID: K043332
• Device Name: WHEELCHAIR, MODEL 8500-II
• Applicant: Cycling and Health Tech. Industry R&D Center
• Product Code: IOR · Physical Medicine
• Decision Date: Dec 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

AIDC 8500-II Wheelchair is a tilt-in-space mobile positioning system for everyday indoor and outdoor use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user. AIDC 8500-II Wheelchair can be an attendant propelled or self propelled device, its intended use is to enhance mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor. It has various options to control and/or support the user's specific needs.

Device Story

Manual, tilt-in-space mechanical wheelchair; provides mobility for physically challenged users. Features TIG-welded AA6061-T6 aluminum alloy tubing frame, removable seat/back upholsteries, flip-up footrests/legrests, front castors, and rear wheels. Operated by user (self-propelled) or attendant. Used in indoor/outdoor environments with firm, flat surfaces. Enhances mobility and provides positioning support. No electronic or software components.

Clinical Evidence

Bench testing only. Compliance testing performed per ANSI/RESNA WC Vol. 1 (Sections 1, 5, 7, 8, 15, 16) and ISO 7176 (Parts 1, 5, 7, 8, 15, 16, 19). Additional testing per California Bureau of Home Furnishings 117 flammability standards.

Technological Characteristics

Manual mechanical wheelchair. Frame: TIG-welded AA6061-T6 aluminum alloy tubing. Components: removable upholstery, flip-up foot/legrests, castors, rear wheels. Standards: ANSI/RESNA WC Vol. 1, ISO 7176, California Bureau of Home Furnishings 117. No energy source, connectivity, or software.

Indications for Use

Indicated for physically challenged persons limited to a sitting position requiring mobility assistance on flat, firm indoor or outdoor terrain.

Regulatory Classification

Identification

A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• Solara Jr. Wheelchair (K012370)

Submission Summary (Full Text)

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DEC 1 3 2004

#### 7. 510(k) summary

# 510(k) Summary

# Aerospace Industrial Development Corporation's

## AIDC 8500-II Wheelchair

## Sponsor's information:

Cycling and Health Tech Industry R&D Center No. 17, 37th Rd., Taichung Industry Park, Taichung, Taiwan Contact person: Jeff Chang Director of Testing Department Phone: [phone] Facsimile: 886-4-22430627 e-mail: [e-mail] Date prepared: November 12, 2004

## Proprietary and Manufacturer information:

Aerospace Industrial Development Corporation (AIDC) 111-X60, Lane 68, Fu-Hsing N. Rd., Taichung, Taiwan Contact person: Zen-Jye Chen Manager of Medical Device Section Phone: [phone] Facsimile: 886-4-22842849 e-mail: [e-mail]

#### Device

Trade name: AIDC 8500-11 Wheelchair Common name: Manual Wheelchair Classification name: Mechanical wheelchair Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3850 Product Code: 89IOR Classification: Class I

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#### Predicate devices

Manufacture name: Invacare Corporation Name: Solara Jr. Wheelchair k number: K012370 Date cleared: 8/3/2001

## Intend use of device

AIDC 8500-II Wheelchair is a tilt-in-space mobile positioning system for everyday indoor and outdoor use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user.

AIDC 8500-II Wheelchair can be an attendant propelled or self propelled device, its intended use is to enhance mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor. It has various options to control and/or support the user's specific needs.

#### Device description:

The AIDC 8500-II Wheelchair is manually operated mechanical wheelchair. It is designed to be light in weight with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles.

The AIDC 8500-II Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of aluminum alloy frame constructed of AA6061-T6 aluminum alloy tubing that is TIG-welded, removable seat and back upholsteries, flip-up available footrest and legrest, front castors and rear wheels.

The owner's manual of AIDC 8500-II Wheelchair provides information on warnings, cautions and operation instruction of the wheelchair.

#### Substantial equivalence:

The AIDC 8500-11 wheelchair is substantially equivalent to the Solara Jr. Wheelchair (K012370) manufactured by Invacare Corporation.

Analysis of comparison of design, function and feature of AIDC 8500-II wheelchair to Solara Jr. Wheelchair (K012370), together with the results of compliance testing to existing ANSI/RESNA, ISO 7176 standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended.

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While there are minor differences in performance specifications of the 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, AIDC believes that the AIDC 8500-II wheelchair is substantially equivalent to legally marketed devices currently in commercial distribution.

## Non-Clinical testing

AIDC 8500-II wheelchairs have been tested to wheelchair standards. They include:

- (1). ANSI/RESNA WC Vol. 1 Sec. 1 Determination of static stability
- (2). ANSI/RESNA WC Vol. 1 Sec. 5 Determination of overall dimensions, mass and turning space
- (3). ANSI/RESNA WC Vol. 1 Sec. 7 Measurement of seating and wheel dimensions
- (4). ANSI/RESNA WC Vol. 1 Sec. 8 Static, impact and fatigue strengths
- (5). ANSI/RESNA WC Vol. 1 Sec. 15 Requirements for the information disclosure, documentation, and labeling
- (6). ANSI/RESNA WC Vol. 1 Sec. 16 Resistance to ignition of upholstered parts
- (7). ISO7176-1 Determination of static stability
- (8). ISO7176-5 Determination of overall dimensions, mass and turning space
- (9). ISO7176-7 Measurement of seating and wheel dimensions
- (10). ISO7176-8 Static, impact and fatigue strengths
- (11).ISO7176-15 Requirements for the information disclosure, documentation, and labeling
- (12). ISO7176-16 Resistance to ignition of upholstered parts
- (13). ISO 7176-19 Wheeled mobility devices for use in motor vehicles
- (14). California Bureau of Home Furnishings 117 Flammability Standards

## Conclusion

.

- Analysis of comparison of design, function and feature of AIDC 8500-11 Wheelchair to Invacare Solara Jr. Wheelchair, together with the results of compliance testing to existing ANSI/RESNA and ISO 7176 standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting, performance criteria and functioning as intended.
The AIDC 8500-II Wheelchair is substantially equivalent to the predicate device and does not raise any issues of safety and effectiveness.

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DEC 1 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cycling and Health Tech Industry R&D Center C/o Mr. Zen-Jye Chen Manager of Medical Device Section Aerospace Industrial Development Corporation (AIDC) 111-X60, Lane 68 Fu-Hsing N. Rd., Taichung Taiwan

Re: K043332

Trade/Device Name: AIDC 8500-II Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: November 12, 2004 Received: December 2, 2004

Dear Mr. Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becalled in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) 77 the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, de necs that have been recident is quire approval of a premarket approval application (PMA). and Cosmotion Free (1108) last the device, subject to the general controls provisions of the Act. The Tourmaly, merceive, market are a ct include requirements for annual registration, listing of general controls provisions of uactice, 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 If your device is elassified (600 wor of als. Existing major regulations affecting your device can may or subject to back as a success 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 r lease of deviloed that i Drimination that your device complies with other requirements of the Act that I Dr Has Intelles and regulations administered by other Federal agencies. You must of any I occur statutes and equirements, 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 - Mr. Zen-Jye Chen

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely, your,

Mark A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3. Device descriptive information 3.1 Statement of indication for use

## Statement of Indications for Use

510(k) Number (if known):

Device Name: ADC 8500-II Wheelchair

Indications for Use:

AIDC 8500-II Wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.

Prescription Use

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 1 of 1

Mark N. Millerson

(Division Sign-On)
Division of General, Restorative,

and Neurological Devices

510(k) Number K043332

(Posted November 13, 2003)