MODIFICATION TO MEDLINE STRIDER MIDI 3

K042763 · Medline Industries, Inc. · INI · Oct 7, 2004 · Physical Medicine

Device Facts

• Record ID: K042763
• Device Name: MODIFICATION TO MEDLINE STRIDER MIDI 3
• Applicant: Medline Industries, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Indications for Use

The intended use of the Medline Strider MIDI 3 scooter is to provide mobility to persons who are limited in their ability to walk for prolonged periods of time. They are intended for the mobility of persons who are both physically and mentally capable of assessing and reacting to any driving situation. The Medline Strider MIDI 3 scooter is constructed for use both indoors and outdoors. They are for use indoors, on pavement, sidewalks, pedestrian zones and areas free from motor traffic. They must not be driven on public roads with the exception of crossing or when no pavements are available.

Device Story

Medline Strider MIDI 3 is a motorized three-wheeled vehicle; provides mobility for individuals with limited walking capacity. Operated by user via tiller/handlebar controls; intended for indoor/outdoor use on sidewalks, pedestrian zones, and pavement. Device assists users in navigating environments; requires user to possess physical/mental capability to assess and react to driving situations. Benefits include increased independence and mobility for patients unable to walk for prolonged periods.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized three-wheeled vehicle; 21 CFR 890.3800; Class II; Product Code INI. Form factor: scooter with tiller steering. Energy source: electric motor/battery powered.

Indications for Use

Indicated for individuals with limited walking ability who are physically and mentally capable of operating a motorized scooter safely. Intended for indoor and outdoor use on pavement, sidewalks, and pedestrian zones; not for use on public roads except for crossing.

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2004

Ms. Andrea Haferkamp Corporate Director of Regulatory Affairs Medline Industries, Inc Durable Medical Equipment One Medline Place Mundelein, Illinois 60060

Re: K042763

Trade/Device Name: Medline Strider MIDI 3 Regulation Number: 21 CFR 890. 3800 Regulation Name: Motorized three- wheeled vehicle Regulatory Class: II Product Code: INI Dated: October 1, 2004 Received: October 5, 2004

Dear Ms. Haferkamp:

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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Page 2 - Ms. Andrea Haferkamp

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 A. Mulhearn

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_

Device Name: Medline Strider MIDI 3

Indications for Use:

The intended use of the Medline Strider MIDI 3 scooter is to provide mobility to I ne method abo of the May walking for prolonged periods of time. They are intended perone and he mobility of persons who are both physically and mentally capable of assessing and reacting to any driving situation.

The Medline Strider MIDI 3 scooter is constructed for use both indoors and outdoors. They are for use indocrs, on pavement, sidewalks, pedestrian zones and areas free from motor traffic. They must not be driven on public roads with the exception of crossing or when no pavements are available.

> X AND/OR Over-The-Counter Use Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mulkerson
Division Sign Off

Division of General, Restorative, and Neurological Devices

**510(k) Number** K042763