TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4

K011753 · Merits Health Products., Inc. · INI · Aug 3, 2001 · Physical Medicine

Device Facts

• Record ID: K011753
• Device Name: TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
• Applicant: Merits Health Products., Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Aug 3, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The intended use of Travel Ease Electric Scooter, Pioneer 4 is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.

Device Story

Travel Ease Electric Scooter, Pioneer 4 is a battery-powered mobility device; intended for adult users with limited mobility; operated by user via simple controls; provides seated transportation; intended for indoor/outdoor use; enhances patient independence by facilitating mobility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electric scooter; battery-powered; mobility aid; class II device; product code INI; regulation 890.3800.

Indications for Use

Indicated for adult persons with mobility limitations who are restricted to a sitting position and possess the physical and cognitive ability to operate simple controls.

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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AUG - 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Winston Anderson Vice President MERITS Health Products, Inc. P.O. Box 150356 Cape Coral, Florida 33915

Re: K011753

Trade/Device Name: Travel Ease Electric Scooter, Pioneer 4 Regulation Number: 890.3800 Regulatory Class: II Product Code: INI Dated: July 25, 2001 Received: July 25, 2001

Dear Mr. Anderson:

We have reviewed your Section 510(k) notification of intent to market the devident of a we nave reviewed your Section 9 rotty neversantially equivalent (for the indications for use above and we nave determined the actreced predicate devices marketed in interstate commerce Stated in the enclosure) to logally manove of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). Tou may, dicrerers, lannovisions of the Act include requirements for annual provisions of the Act. "The general controls process and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Fremarket Approval), it may of sale of Federal Regulations, Title 21, Parts 800 to 895. arreculty equivalent determination assumes compliance with the Current Good A substantially equirements, 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 mispections, the rood and Drag result in regulatory action. In addition, FDA may publish comply with the GMT Togalazer and our device in the Federal Register. Please note: this response to your premarket notification submission does 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 regulations.

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Page 2 - Mr. Winston Anderson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. The I Driving of castion 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 and 11 you desire specific arriver diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in viao alaguestions on the promotion and advertising of your device, [phone]. entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on your responsibility free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Amuleeson on

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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## K011753

Page 1 of 1

ROOM STATE 510(k) Number (if known);

Travel Ease Electric Scooter, Pioneer 4 Device Name:

Indications For Use:

The intended use of Travel Ease Electric Scooter, Pioneer 4 is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.

elbert C. Cole
William Anderson

Winston Anderson Vice President Merits Health Products, Inc.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

osmithelity so career (Division Sign-Off) Division of General, Restorative

and Neurological Devices

Kollars 510(k) Number -Over-The-Counter Use V Prescription Use OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)