OVERLANDER PEV 2000

K983497 · Raye'S, Inc. · ITI · Jun 27, 1999 · Physical Medicine

Device Facts

• Record ID: K983497
• Device Name: OVERLANDER PEV 2000
• Applicant: Raye'S, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Jun 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Intended Use

The power wheelchair is used as a mobility device for individuals who have limited mobility. The wheelchair is designed especially for larger individuals and can be used for outside mobility or in clinical applications.

Device Story

The Overlander PEV 2000 is a power wheelchair designed for mobility assistance. It is intended for use by individuals with limited mobility, with a specific design focus on larger users. The device is operated by the user for personal mobility in outdoor environments or within clinical settings. It functions as a motorized transport platform to improve patient independence and mobility. No complex data processing, AI, or software-based analysis is involved in its operation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Power wheelchair; motorized mobility device; designed for larger individuals; intended for outdoor and clinical use.

Indications for Use

Indicated for individuals with limited mobility, specifically designed for larger individuals, for use in outside mobility or clinical applications.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 29 1999

Mr. Willard L. Frickey President and CEO Wheelchairs of Kansas P.O. Box 320 204 West 2nd Street Ellis. Kansas 67637

K983497 Re: Trade Name: Overlander PEV 2000 Regulatory Class: II Product Code: ITI Dated: March 1. 1999 Received: May 3, 1999

Dear Mr. Frickey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Willard L. Frickey

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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Image /page/2/Picture/0 description: The image is a logo for "Wheelchairs of Kansas". The logo is in black and white and features a stylized wheelchair in the shape of the state of Kansas. The phone number 1-800-537-6454 and fax number 800-337-2447 are listed below the company name.

P.O. Box 320 · 204 W. 2nd St. · Ellis. KS 67637

Raye's INC. 204 West 2nd Street Ellis, KS 67637

510 (k) Number: K983497

Service Name: Overlander PEV 2000

## Indication – or Use:

The power wheelchair is used as a mobility device for individuals who have limited The power which is assult is assult in the wheelchair is designed especially for larger individuals and can be used for outside mobility or in clinical applications.

Wilbur Hunch

Willard Lee Frickey, President Wheelchairs of Kansas

## 11-8-98

Date

Pcotleffo

(Director, Offi
D. eneral Restorative Devices K9834
510(K) Number

Over-the-Counter Use X

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