RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,

K032402 · Convaid Products, Inc. · IOR · Sep 24, 2003 · Physical Medicine

Device Facts

• Record ID: K032402
• Device Name: RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,
• Applicant: Convaid Products, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Sep 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

The Rodeo manual wheelchairs are a tilt in space mobile positioning system for everyday use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user. It is an attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position.

Device Story

Rodeo manual wheelchair; tilt-in-space mobile positioning system; attendant-propelled. Frame constructed of powder-coated round tubular steel; features 6" front casters and 8" rear wheels. Provides 10°-45° adjustable tilt and 90°-105° seat-to-back angle adjustment. Designed for everyday indoor/outdoor use on firm, flat terrain. Available in multiple sizes; includes transit option for use in motor vehicles. Attendant adjusts positioning to support user needs; provides mobility for individuals limited to sitting position. Benefits include improved mobility and postural support for patients with various immobilizing conditions.

Clinical Evidence

Bench testing only. Device met performance requirements specified in ANSI/RESNA WC vol. 1 and ISO 7176 standards, including fatigue strength, dimensions, and ANSI/RESNA W/C 19 for use as seating in motor vehicles.

Technological Characteristics

Manual, folding, tilt-in-space wheelchair. Materials: powder-coated round tubular steel (5/8" to 1" diameter). Features: 6" front casters, 8" rear wheels, adjustable seat depth, footplate, and push handle height. Upholstery meets California Technical Bulletin CAL 117 flame retardancy standards. Complies with ANSI/RESNA WC vol. 1 and ISO 7176 standards.

Indications for Use

Indicated for individuals with limited mobility due to conditions including: amputee, arthritis, arthrogriposis, cerebral palsy, geriatric conditions, head injury/trauma, hemiplegia, multiple sclerosis, muscular dystrophy, paraplegia, polio, quadriplegia, spina bifida, stroke/CVA, tetraplegia, or other immobilizing/debilitating conditions such as spinal cord injuries and extremity paralysis.

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

• Quickie Zippie TS Folding Model (K952641)

Reference Devices

• Quickie TSR (K952641)
• Quickie/Zippie Series (K973673)

Submission Summary (Full Text)

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K032402

FP 2 4 2003

Image /page/0/Picture/2 description: The image shows the logo for Convaid Products Inc. The logo consists of a black square with a white curved line running through it, followed by the word "Convaid" in bold, sans-serif font. Below "Convaid" is the text "PRODUCTS INC" in a smaller, thinner font.

P.O. Box 4209 · Palos Verdes, CA 90274 USA Toll Free (888) CONVAID (266-8243) or [phone] [phone] * Fax. [phone]

> Convaid Product Inc. Model: RODEO Manual Wheelchair

> > 510(k) Summary of Safety and Efficacy

## A. General Information

| 1. | Submitter Name: | Convaid Products Inc. |
|----|----------------------|--------------------------------------------|
| 2. | Address: | 2830 California St.<br>Torrance CA, 90503 |
| 3. | Telephone: | 310-618-0111 |
| | Fax: | 310-618-2166 |
| 4. | Contact Person: | Donald Griggs<br>Quality Assurance Manager |
| 5. | Registration Number: | 2022883 |

- Date Prepared: 6.
## B. Device

| 1. | Device Trade Name: | Rodeo - Mobile Positioning System |
|----|-----------------------------|-----------------------------------|
| 2. | Common/Generic Name: | Wheelchair-folding tilt in space |
| 3. | Device Classification Name: | Mechanical Wheelchair |
| 4. | Registration Number: | 222022883 |
| 5. | Product Code: | IOR |
| 6. | Device Classification | Class 1 |
| 7. | Regulatory Number: | 980.3850 |

- Manufacture Name: Sunrise Medical ﺍ

| 1. | Manufacture Name: | Sunrise Medical |
|----|-------------------|-----------------|
| 2. | Name: | Quickie TSR |
| 3. | K Number: | K952641 |

- K Number: ે. 4. Date Cleared: 07/06/1995
-
- Manufacture Name: Sunrise Medical 1.
- Quickie Zippie Series 2. Name:
- 3. K Number: K973673
- 11/20/1997 4. Date Cleared:

## D. Intended Use

The Rodeo manual wheelchairs are a tilt in space mobile positioning system for everyday use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user. It is an attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position.

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Image /page/1/Picture/0 description: The image shows the logo for Convaid Products Inc. The logo consists of a black square with a white curved line running through it, followed by the word "Convaid" in bold, black letters. Below "Convaid" is the phrase "PRODUCTS INC" in a smaller, thinner font.

P.O. Box 4209 · Fialos Verges. Toll Free (888) CON) 4.5 (266-8. 1181552-1020

## E. Description of the device

The Rodeo model is constructed of the same materials and contains the same typical components found on most manual wheelchairs. The frame consists primarily of powder coated round tubular steel from 5/8" to 1" diameter, that is welded, bolted and riveted. With 6" front wheels attached to pivoting casters for steering and turning, and 8" wheels in the rear. The product is a lightweight folding or non-rigid type wheelchair, which is designed for everyday indoor or outdoor use on firm terrain. Also available with a transit option for use in approved transport vehicles. The Rodeo offers its users a 10°-45° of adjustable tilt and 90°-105° of seat to back angle adjustment and comes with a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy. Adjustable seat depth, footplate and height of push handle.

#### F. Technological Characteristics Summary

The Rodeo wheelchair is substantially equivalent to

Sunrise Medicals Quickie Model "Zippie TS Folding Model"

The Sunrise Medical "Quickie TSR" was cleared 07/06/1995 on K952641.

Also reference Sunrise Medicals Quickie/Zippie Series cleared 11/20/1997 on K973673.

Sunrise Medicals "Zippie TS folding frame" and Convaid's "Rodeo" wheel chairs are a tilt-in-space mobility system, manual wheelchair for everyday use, both frames are built using tubular steel that is welded, bolted and riveted. They are a folding non-rigid wheelchair and use a compression folding system that allow for easy transport and storage. The Convaid Rodeo is an attendant propelled manual design and does not come with the Zippie TS option to be self-propelled. Adjustable push handle height, and adjustable back angle, adjustable seat depths. Similar seat widths and weights.

### G: Comparison of device characteristics to predicate

This device (Convaid Rodeo) has similar characteristics, construction and technology as the predicate device manufactured by Sunrise Medical the Zeppie TS folding model.

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Image /page/2/Picture/0 description: The image shows the logo for Convaid Products Inc. The logo consists of a black square with a white curved line running through it, resembling a road. To the right of the square is the text "Convaid" in a bold, sans-serif font, and below that is "PRODUCTS INC" in a smaller, thinner font.

P.O. Box 4209 • Palos Verdes, CA 90274 USA Toll Free (888) CONVAID (266-8243) or [phone] [phone] · Fax: [phone]

# H: Target Population:

This device is indicated for individuals with the specific medical conditions Listed, but the indications are not necessarily limited to such conditions:

- Amputee;
- Arthritis:
- Arthrogriposis;
- Cerebral Palsy;
- Geriatric conditions;
- Head injury or trauma;
- Hemiplegics;
- Multiple Scierosis;
- Muscular Dystrophy;
- Paraplegic;
- Polio;
- Quadriplegic;
- Spina Bifida;
- StokeJCVA;
- Tetraplegic; and
- Other immobilizing or debilitating conditions, including spinal cord injuries and Other lower and upper extremity paralysis

# I: Non-Clinical Testing

Convaid's Rodeo manual wheelchairs meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 or ISO 7176 Wheelchair Standards as indicated in section 2 page 2-3. Including ANSI/RESNA W/C 19 Wheelchair use as seating in motor vehicles.

### J: Safety:

The Convaid Rodeo Wheelchair Series is substantially equivalent to the predicated device listed in the 510(k); the technology and construction of the Rodeo Wheelchair series does not raise any new issues of safety and effectiveness.

### K: Conclusion:

The Rodeo Wheelchair series shares performance features and technology with a number of devices already legally marketed within the United States. Therefore, the Rodeo Series wheelchairs are substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a symbol that looks like three stylized human profiles or a caduceus without the staff.

Public Health Service

SEP 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald Griggs Quality Assurance Manager Convaid Products, Inc. 2830 California Street Torrance, California 90503

Re: K032402

Trade/Device Name: Rodeo Models RD12, RD14, RD16 Rodeo Transit Models RD12T, RD14T and RD16T Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: I Product Code: IOR Dated: July 28, 2003 Received: August 4, 2003

Dear: Mr. Griggs:

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 (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. Donald Griggs

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,

Mark N Melleman

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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Voluntary performance standard:

Non-Clinical Testing of Convaid's Rodeo manual wheelchairs meet the applicable performance requirements as specified in the following ANSI/RESNA or ISO Wheelchair Standards.

Determination of Overall Dimensions, Mass and Turning Space ANSI/RESNA W/C 5 ISO 7179- 8-10 Fatigue Strength Test ANSI/RESNA W/C 15 Documentation and Labeling ANSI/RESNA W/C 16 Flammability ANSI/RESNA W/C 19 Wheelchair use as seating in motor vehicles

# Statement of Indication of use

Convaid's Rodeo manual wheelchairs and Sunrise Medical Zippie TS are a tilt in space mobile positioning system for everyday indoor and outdoor use on flat firm terrain. They are available in a range of sizes to accommodate a particular fit to the user. The Convaid Rodeo is a attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position. It has a variety of options to control or support the users specific needs.

## Target Population:

This device is indicated for individuals with the specific medical conditions Listed, but the indications are not necessarily limited to such conditions:

- Amputee:
- Arthritis;
- Arthrogriposis;
- Cerebral Palsy;
- Geriatric conditions;
- Head injury or trauma;
- Hemiplegics;
- Multiple Sclerosis;
- Muscular Dystrophy;
- Paraplegic;
- Polio:
- Quadriplegic;
- Spina Bifida;

- StokeJCVA;

- Tetraplegic; and
- Other immobilizing or debilitating conditions, including spinal cord injuries and Other lower and upper extremity paralysis

Mark N. Malkerson

eral. Restorative

510(k) Number_