MEDLINE PEDIATRIC WHEELCHAIRS

K053574 · Medline Industries, Inc. · IOR · Jan 25, 2006 · Physical Medicine

Device Facts

• Record ID: K053574
• Device Name: MEDLINE PEDIATRIC WHEELCHAIRS
• Applicant: Medline Industries, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Jan 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

Medline Pediatric Wheelchairs provide mobility for individuals restricted to a sitting position. Device is a mechanical wheelchair; operated by patient or caregiver; used in clinical or home settings. Provides manual transport; improves patient independence and mobility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical wheelchair; manual operation; intended for pediatric use. No electronic components, software, or specific material standards cited.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2006

Ms. Lara N. Simmons Director, Quality Assurance Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060

Re: K053574

Trade/Device Name: Medline Pediatric Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: December 19, 2005 Received: December 22, 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 Fedcral 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 - Ms. Simmons

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" (21 CFR 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/industry/support/index.html.

Sincerely vours,

Mark N. Melkerson

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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cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 Division D.O. f/t:EXE:rrr: 1/11/06

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510(k) Number (if known):_ 上の53574

Medline Pediatric Wheelchairs Device Name:

Indications for Use:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __xx (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number__

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