TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5

K013788 · Merits Health Products Co., Ltd. · INI · Dec 11, 2001 · Physical Medicine

Device Facts

• Record ID: K013788
• Device Name: TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
• Applicant: Merits Health Products Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Dec 11, 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 5 is to provide mobility to adult persons limited to a sitting position and capable of operating a few simple controls.

Device Story

Travel Ease Electric Scooter, Pioneer 5 is a motorized three-wheel vehicle designed to provide mobility for adults with limited physical mobility. The device is operated by the user via simple controls. It functions as a personal transport aid for individuals who must remain in a seated position. It is intended for use in various environments to assist with independent movement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized three-wheel vehicle (Product Code: INI). Class II device under 21 CFR 890.3800.

Indications for Use

Indicated for adult persons with limited mobility who are capable of sitting and operating 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 1 2001

Winston Anderson Vice President Merits Health Products Company, LTD. P.O. Box 150356 Cape Coral, Florida 33915

Re: K013788

Trade Name: Travel Ease Electric Scooter, Pioneer 5 Regulation Number: 890.3800 Regulation Name: Motorized Three Wheel Vehicle Regulatory Class: II Product Code: INI Dated: November 1, 2001 Received: November 14, 2001

Dear Mr. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your booted esternined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to muleations for use success in the energent medical Device Amendments, or to devices that have May 20, 1970, the chaonsance 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 therefore, marker the do received to equirements for annual registration, listing of devices, Controls provisions or the ice, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to been as a success Regulations, Title 21, Parts 800 to 898. In addition, FDA may ov loand interest announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toure of actived 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 or any I 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 forth in and quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Winston Anderson

This letter will allow you to begin marketing your device as described in your Section 510(k) This icher with anow you're ough finding of substantial equivalence of your device to a legally premaired 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 and IT you desire specific acrise for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fut 0091. Additionally, for questions on the promotion and advertising of Compliance at [phone] - 1859 - 155 - 15 - 15 - 4639. Also, please note the your do roo, pitude while by reference to premarket notification" (21CFR Part 807.97). I general information on your responsibilities under the Act may be obtained from the Outcr general intonnation on one of the mational 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,

Susan Walker, MS

Celia M. Witten, Ph.D., M.D. 0 لس Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1013788/A'

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510(k) Number (if Known): K013788

Device Name: Travel Ease Electric Scooter, Pioneer 5

Indications for Use:

The intended use of Travel Ease Electric Scooter, Pioneer 5 is to provide mobility to adult persons limited to a sitting position and capable of operating a few simple controls.

leRida

Winston Anderson Vice President Merits Health Products, Inc.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescripton Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional format 1-2-96)

Susan Walker m

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

510(k) Number k013788

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