TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3

K011751 · Merits Health Products., Inc. · INI · Aug 6, 2001 · Physical Medicine

Device Facts

• Record ID: K011751
• Device Name: TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
• Applicant: Merits Health Products., Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Aug 6, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The intended use of the MERITS Pioneer 3 Powered Scooter is to provide mobility to adults, limited to a siting position and have the capability to operate a simple hand control.

Device Story

MERITS Pioneer 3 is an electric-powered four-wheel scooter designed to provide mobility assistance. The device is operated by the user via simple hand controls while in a seated position. It functions as a personal mobility aid for individuals with limited mobility. The device is intended for use by adults who possess the physical and cognitive capability to safely operate the hand controls. It serves to enhance patient independence by facilitating movement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electric-powered four-wheel scooter; hand-controlled operation; intended for adult use in a seated position. No specific materials, software, or connectivity details provided.

Indications for Use

Indicated for adults with limited mobility who are capable of operating a hand control and require a seated position for mobility.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of flowing lines, possibly representing people or services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2001

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

Re: K011751

Trade/Device Name: MERITS Pioneer 3 Electric Powered Four Wheel Drive Scooter 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 above and we 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). 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 (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.

{1}------------------------------------------------

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 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office 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,

hllllllllllmnon

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

{2}------------------------------------------------

## Indications for Use Statement

510K number: K011751

Device Name: MERITS Pioneer 3 Electric powered four wheel drive scooter

The intended use of the MERITS Pioneer 3 Powered Scooter is to provide Indications For Use: mobility to adults, limited to a siting position and have the capability to operate a simple hand control.

K.P.

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number_

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

DTHuleeeow fr cmu

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

510(k) Number K011751