INDEPENDENCE 324

K990484 · Eagle Parts & Products, Inc. · ITI · Jun 25, 1999 · Physical Medicine

Device Facts

• Record ID: K990484
• Device Name: INDEPENDENCE 324
• Applicant: Eagle Parts & Products, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Jun 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

THE INDEPENDENCE 324 IS INTENDED TO AID IN THE TEMPORARY OR PERMANENTLY MOBILITY IMPAIRED INDIVIDUAL TO MOVE ABOUT INDOORS, AND OUTDOORS, THROUGH THE USE OF A BATTERY POWERED, MOTORIZED THREE-WHEELED VEHICLE. THE WEIGHT CAPACITY OF THE INDIVIDUAL IS NOT TO EXCEED 300 LBS.

Device Story

Independence 324 is a battery-powered, motorized three-wheeled vehicle; designed to assist mobility-impaired individuals with indoor and outdoor navigation. Operated by the user; device provides powered locomotion to compensate for physical limitations. Output is physical transport of the user. Benefits include increased independence and mobility for patients weighing up to 300 lbs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-powered, motorized three-wheeled vehicle. Maximum weight capacity 300 lbs.

Indications for Use

Indicated for individuals with temporary or permanent mobility impairment requiring assistance for indoor and outdoor mobility. Maximum patient weight capacity is 300 lbs.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1999

Charles B. Walker, Jr. Mr. Sales and Marketing Manager Eagle Parts and Products, Inc. 1811 Wilkinson Road Auqusta, Georgia 30904

Re : K990122 Independence 624 Trade Name : K990484 Independence 324 Trade Name : Regulatory Class: II Product Code: ITI Dated: Undated Received: April 30, 1999

Dear Mr. Walker:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does

{1}------------------------------------------------

Page 2 - Mr. Charles B. Walker, Jr.

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 requlations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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

Enclosures

{2}------------------------------------------------

## STATEMENT OF INDICATED USE

K990484

The INDEPENDENCE 324 IS INTENDED TO AID IN THE TEMPORARY OR PERMANENTLY MOBILITY IMPAIRED INDIVIDUAL TO MOVE ABOUT INDOORS, AND OUTDOORS, THROUGH THE USE OF A BATTERY POWERED, MOTORIZED THREE-WHEELED VEHICLE. THE WEIGHT CAPACITY OF THE INDIVIDUAL IS NOT TO EXCEED 300 LBS.

Chute B. Ward

Charles B. Walker Jr

**Over-the-Counter Use** X

pased

(y-Off)

of General Re 4048 5 | U(k) Number