EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR

K051302 · Medline Industries, Inc. · IOR · Aug 15, 2005 · Physical Medicine

Device Facts

• Record ID: K051302
• Device Name: EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR
• Applicant: Medline Industries, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Aug 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Indications for Use

Medline Bariatric Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.

Device Story

Medline Bariatric (Shuttle) Wheelchair is a mechanical mobility device designed for bariatric patients restricted to a sitting position. It functions as a manual wheelchair to provide transport and mobility. Operated by the patient or an assistant in clinical or home settings. Device provides physical support and mobility; no electronic or automated components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical wheelchair; manual operation; bariatric-rated frame construction. No electronic components, software, or energy sources.

Indications for Use

Indicated for persons restricted to a sitting position requiring mobility assistance. No specific age or gender restrictions noted.

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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, facing to the left. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2005

Ms. Lara N. Simmons Corporate Director, Regulatory Affairs Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060-4486

Re: K051302

Trade/Device Name: Medline Bariatric (Shuttle) Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 3, 2005 Received: August 4, 2005

Dear Ms. Simmons:

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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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 yours,
Mark N. Milliken

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

Enclosure

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Page Page 2 of

510(k) Number (if known): _

Device Name: Medline Bariatric (Shuttle) Wheelchair

Indications for Use:

Medline Bariatric Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use XX

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(PLEASE DO NOT WRITE BLOEW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Milliken

Vision Sign-Off) ivision of General, Restorative Marrolarical Douges

Number K051302

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