MARVEL WHEELCHAIR, MODEL EDCAL01

K082970 · Rogue Wheels, Inc. · IOR · Dec 12, 2008 · Physical Medicine

Device Facts

• Record ID: K082970
• Device Name: MARVEL WHEELCHAIR, MODEL EDCAL01
• Applicant: Rogue Wheels, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Dec 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

The Marvél Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.

Device Story

Marvél Wheelchair is a manually operated, user-propelled mechanical device; provides mobility for individuals restricted to seated positions. Constructed with aluminum frame and titanium elements for weight reduction and vibration dampening; features large rear wheels with handrims and front pivoting casters. Rigid, non-folding design; modular components allow adjustment of seat height, width, and angles for user comfort. Operated by the user in indoor and outdoor environments; excludes stair use. Device facilitates independent mobility and lifestyle customization through replaceable parts.

Clinical Evidence

Bench testing only. The device meets the performance requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs."

Technological Characteristics

Manual mechanical wheelchair; rigid, non-folding frame. Materials: aluminum frame with titanium elements. Components: caster wing assembly, main frame assembly, seating assembly. Adjustable seat height, width, and angle. Complies with ANSI/RESNA WC/Vol. 1-1998 standards.

Indications for Use

Indicated for persons restricted to a seated position requiring mobility assistance. Suitable for indoor and outdoor use, excluding stairs.

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

• Stryker Sorano Wheelchair (K051369)

Submission Summary (Full Text)

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K082970

Marvél Wheelchair

Rogue Wheels Inc. Traditional 510(k)

DEC 1 2 2008

# 510(k) Summary of Safety and Effectiveness

| Manufacturer Name: | Rogue Wheels Inc. |
|--------------------|------------------------------------|
| Postal Address: | 171 East Liberty Street, Unit #102 |
| | Toronto, Ontario |
| | Canada M6K 1W9 |
| Phone Number: | 416-535-2939 |
| Fax: | 416-535-7376 |
| Contact: | Jeff Adams |
| Title: | President |
| Date: | October 3, 2008 |

| Device Proprietary Name: | Marvél Wheelchair |
|------------------------------|-----------------------|
| Device Common or Usual Name: | Mechanical Wheelchair |
| Classification Name: | Wheelchair Mechanical |
| Classification Code | IOR - Class I |
| Classification Panel | Physical Medicine |
| Regulation Number | 890.3850 |

#### Predicate Device

Substantial equivalence is claimed to the following device as related to intended use and design characteristics:

- Stryker Sorano Wheelchair, K051369 .
#### Intended Use

The Marvel Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.

#### Description of the Device

The Marvél Wheelchair is a manually operated, user propelled mechanical wheelchair. It is intended to provide mobility to persons restricted to a seated position. It can be operated on most indoor and outdoor surfaces, with the exception of stairs.

The frame is constructed primarily of aluminium but with titanium elements in specific areas to reduce vibration and weight. Large rear wheels with handrims propel the chair and smaller front pivoting casters provide stability. The wheelchair is a lightweight manual chair designed for everyday use, both indoors and outdoors. The wheelchair is a rigid, non-folding type wheelchair.

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### Rogue Wheels Inc. Traditional 510(k)

The Marvel wheelchair consists of three major components or sections in addition to the large rear whecls: the caster wing assembly, the main frame assembly and the seating assembly.

The Marvel Wheelchair offers modularity and a number of adjustability features. The seat height, width, angle, rear seat-to-floor height, and front seat-to-floor height may be adiusted easily for the comfort of the user. Modularity allows replacement of worn components and allows the user to continually customize their own chair to ensure optimal functionality for their lifestyle.

#### Performance Data:

The Marvél Wheelchair will meet the applicable performance standards specified in Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs".

#### Substantial Equivalence

The Marvel Wheelchair is similar to the Stryker Sorano Wheelchair based on the intended use, design, technology, material composition and performance.

#### Conclusion

The Marvél Wheelchair does not raise any new safety and efficacy concerns when compared to a similar legally marketed device. Therefore, the Marvel Wheelchair is substantially equivalent to the predicate device identified above.

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Image /page/2/Picture/0 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 body and wing. The eagle is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2008

Rogue Wheels Inc. % CanReg Inc. Kathryn Ronalds, RAC Regulatory Affairs Manager, Devices 4 Innovation Drive Dundas, Ontario Canada L9H 7P3

Re: K082970

Trade/Device Name: Marvél Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair. Regulatory Class: Class I Product Code: IOR Dated: October 3, 2008 Received: October 6, 2008

Dear Ms. Ronalds:

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.

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Page 2 -- Ms. Kathryn Ronalds

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 liasting (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 est so product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 1egally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliary, pro [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number:

Device Name:

Marvél Wheelchair

:

Indication for Use:

The Marvél Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use __X (21 CFR Part 801 Subpart C)

.

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation

| Division Sign-Off | |
|-----------------------------|---------|
| Office of Device Evaluation | |
| 510(k) | k082570 |

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | k082970 |
|---------------|---------|
|---------------|---------|

September 1998