CHEETAH WHEELCHAIR

K033460 · R82 A/S · IOR · Mar 26, 2004 · Physical Medicine

Device Facts

• Record ID: K033460
• Device Name: CHEETAH WHEELCHAIR
• Applicant: R82 A/S
• Product Code: IOR · Physical Medicine
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The Cheetah Wheelchair is designed for children who have physical impairments that require the use of a device to assist them with their mobility needs. This device is intended solely for pediatric use.

Device Story

Cheetah Wheelchair is a mechanical mobility aid for pediatric patients with physical impairments. Device provides support and mobility assistance to children. Operated by the patient or caregiver. Used in home or clinical settings. Simple mechanical design; no electronic or software components.

Clinical Evidence

No clinical data provided; device is a mechanical wheelchair.

Technological Characteristics

Mechanical wheelchair; manual operation; pediatric form factor. No electronic components, software, or energy sources.

Indications for Use

Indicated for pediatric patients with physical impairments requiring mobility assistance.

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.

Submission Summary (Full Text)

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Public Health Service

MAR 2 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

R82 A/S C/o Kirk L. MacKenzie President Snug Seat, Inc. 12801 East Independence Boulevard Stallings, North Carolina 28105

Re: K033460

Trade/Device Name: Cheetah Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 16, 2004 Received: March 16, 2004

Dear Mr. MacKenzie:

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 - Kirk L. MacKenzie

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 vours.

Mark A. Millerson

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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## INDICATIONS FOR USE

510(k) Number: K033460

CHEETAH WHEELCHAIR Device Name:

The Cheetah Wheelchair is designed for children who have Indications For Use: physical impairments that require the use of a device to assist them with their mobility needs. This device is intended solely for pediatric use.

Aril

(Signature of Certifier)

Tobias Moeller (Typed Name)

15-12-63
(Dated)

| Prescription Use | AND/OR | Over-The-Counter Use | X |
|-----------------------------|--------|------------------------|---|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) | |

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K033460 |
|---------------|---------|
|---------------|---------|

SK31

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