TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2

K011707 · Merits Medical Industries Co., Ltd. · INI · Aug 3, 2001 · Physical Medicine

Device Facts

• Record ID: K011707
• Device Name: TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
• Applicant: Merits Medical Industries Co., Ltd.
• 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 2 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 2 is a battery-powered mobility device; provides transportation for individuals with limited mobility; operated by user via simple controls; intended for adult users capable of sitting; provides independent mobility; functions as a motorized scooter.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electric scooter; battery-powered; motorized mobility aid; Class II device; product code INI; regulation 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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Public Health Service

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: K011707

Trade/Device Name: Travel Ease Electric Scooter, Pioneer 2 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 device referenced we nave 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 stired in the energently to regionent date of the Medical Device Amendments, or to devices that price to rial) 20, 20, 2011, 11:45 provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costions of the Act. The general controls provisions of the Act include requirements for annual provisions of 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your 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 I ntification. 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 and 11 you active 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for millionally, for questions on the promotion and advertising of your device, (2017) 594-1639. I rush of Compliance at [phone]. Also, please note the regulation 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 Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mmmhhmma

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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K011707

Page_of_of____________________________________________________________________________________________________________________________________________________________________

Comments of the comments of 510(k) Number (if known):

Travel Ease Electric Scooter, Pioneer 2 Device Name:_

Indications For Use:

The intended use of Travel Ease Electric Scooter, Pioneer 2 is to provide mobility to adult persons limited to a sitting position and capable of operating a few simple controls.

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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)

MAMuhleUDO for ann

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

510(k) Number K071707
OR Over-The-Counter UseX

(Optional Format 1-2-96)

Prescription Use (Per 21 CFR 801.109)