INDEPENDENCE 624

K990122 · Eagle Parts & Products, Inc. · ITI · Jun 25, 1999 · Physical Medicine

Device Facts

• Record ID: K990122
• Device Name: INDEPENDENCE 624
• 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

Indications for Use

the temp permanently mobility impaired individual to move about in doors, and out through the use of a battery powere wheeled device. Weight capacity individual not to exceed 250 l

Device Story

Independence 624 and 324 are battery-powered wheeled mobility devices designed for permanently mobility-impaired individuals. Operated by the user to facilitate indoor and outdoor movement. Supports users up to 250 lbs. Provides independent mobility; enhances patient quality of life by enabling navigation in various environments.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Battery-powered wheeled mobility device. Class II. Product Code: ITI.

Indications for Use

Indicated for permanently mobility-impaired individuals requiring indoor and outdoor mobility assistance via a battery-powered wheeled device. Maximum weight capacity: 250 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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1999

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

Re: K990122 Independence 624 Trade Name: K990484 Independence 324 Trade Name: Requlatory 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 aqainst 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 Requlations, 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 Druq 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

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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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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

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K990122/A'

FDA/CDPH/ODE/D

3 23 PM *99

Page

NUMBER (IF KNOWN): K990122 EPENDENCE 624

INDICATIONS FOR USE:

the temp permanently mobility impaired individual to move about in doors, and out through the use of a battery powere wheeled device. Weight capacity individual not to exceed 250 l

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oncurrence of CDRH, Office of Device Evaluation (

Prescription Us (Per 21 CFR 801. OR

-The-Counter Optional Format

Division Sign-Out
Division of General Restorative Devices
510(k) Number
K4