TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114

K080288 · Mega Motion, Inc. · INI · Feb 15, 2008 · Physical Medicine

Device Facts

• Record ID: K080288
• Device Name: TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114
• Applicant: Mega Motion, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Feb 15, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The intended use of the Mega Motion, Inc, Travel Pal Four Wheel Scooter is to provide mobility to persons that have limited walking capabilities or simply those who wish to ride a scooter for transportation purposes.

Device Story

Battery-operated compact four-wheel scooter; features digital controller, adjustable molded plastic seat, foldable tiller, solid frame, and off-board charger. Includes electronic regenerative/electromechanical disc brakes and rear anti-tip wheels for safety. Operated by user for mobility assistance in various environments. Provides transportation for individuals with limited walking capabilities. Performance and stability enhanced by four-wheel configuration compared to three-wheel predecessor.

Clinical Evidence

No clinical data. Device safety and effectiveness supported by non-clinical bench testing, including static/dynamic stability, brake effectiveness, energy consumption, obstacle climbing, and electromagnetic compatibility per ANSI/RESNA standards.

Technological Characteristics

Battery-operated motorized scooter; digital controller; molded plastic seat; foldable tiller; solid frame; electronic regenerative/electromechanical disc brakes; rear anti-tip wheels. Compliance with ANSI/RESNA WC series standards (stability, brakes, energy, dimensions, strength, EMC) and CAL 117 flammability testing.

Indications for Use

Indicated for persons with limited walking capabilities or individuals requiring a scooter for transportation purposes.

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.

Predicate Devices

• Travel Pal Three Wheel Scooter (K060697)

Submission Summary (Full Text)

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Exhibit 1

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# ducts for Better Livl

Travel Pal 4 Wheel Scooter 510(k) Summary

#### Submitter's Name & Address:

Name of Device and Proprietary Name:

Contact Person:

Date Prepared:

Mega Motion, Inc. 957 Wood Street Old Forge, Pa. 18518 Phone: [phone] Facsimile: [phone]

Tom Amico Official Correspondent

01-29-08

Travel Pal Four Wheel Scooter / Mega Motion

Four - Wheel Power Scooter

Vehicle, Motorized 3 -Wheeled

INI

## Device Description:

Product Code:

Classification Name:

Common or Usual Name:

The Travel Pal Four - Wheel Scooter is a battery-operated compact scooter equipped with a digital controller. Features include an adjustable and removable molded plastic seat, a foldable tiller, one-piece solid frame, and an off board charger, designed for ultimate performance, stability and portability. Additional features include electronic regenerative / electromechanical disc brakes, and rear anti-tip wheels designed for ultimate safety.

The Travel Pal Four Wheel Scooter is to be marketed for, but not limited to Mega Motion, Inc. providers / retailers and their consumers.

### Comparison to Predicate Device:

The Travel Pal Four Wheel Scooter is a four-wheel version of the Mega Motion, Travel Pal Three Wheel Scooter (K060697) having similar components to justify substantial equivalence. The additional front wheel increases stability, however, components and performance characteristics are identical to the three wheel model, and achieve the same intended use function.

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Image /page/1/Picture/0 description: The image shows the words "Mega Motion, Inc." in a stylized, three-dimensional font. The text is black and appears to be slightly tilted to the right. The font gives the impression of depth and movement, which aligns with the name "Mega Motion".

## Products for Better Living

#### Intended Use:

The intended use of the Mega Motion, Inc, Travel Pal Four Wheel Scooter is to provide mobility to persons that have limited walking capabilities or simply those who wish to ride a scooter for transportation purposes.

#### Non-Clinical Testing:

Compliance to applicable Testing Standards is as follows: ANSI/RESNA WC/01 Determination of Static Stability ANSI/RESNA WC/02 Determination of Dynamic Stability ANSI/RESNA WC/03 Effectiveness of Brakes ANSI/RESNA WC/04 Determination of Energy Consumption - Theoretical Range ANSI/RESNA WC/05 Overall Dimensions, Mass & Turning Space ANSI/RESNA WC/08 Test methods for Static, Impact and Fatigue Strengths ANSI/RESNA WC/09 Climatic Tests ANSI/RESNA WC/10 Obstacle Climbing ANSI/RESNA WC/14 Power and Controls ANSI/RESNA WC/15 Documentation and Labeling ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility. ANSI/RESNA WC/93 Maximum Overall Dimensions CAL 117 - Flammability Testing

## Discussion of Clinical Testing Performed:

N/A

### Conclusions:

The Travel Pal Four Wheel Scooter has the same intended use and similar technological characteristics as the Travel Pal Three Wheel Scooter (K060697), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Travel Pal Four Wheel Scooter is substantially equivalent to the Travel Pal Three Wheel Scooter predicate device. The Travel Pal Four Wheel Scooter has passed all the necessary testing procedures and is considered to be safe for user operation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

FEB 1 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mega Motion, Inc. c/o Mr. Tom Amico 957 Wood Street Old Forge, PA 18518

Re: K080288

> Trade/Device Name: Travel Pal - Four Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: January 29, 2008 Received: February 4, 2008

Dear Mr. Amico:

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 – Mr. Tom Amico

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson 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): K

### Device Name: Travel Pal – Four Wheel { cooter

#### Indications for Use:

The intended use of the Mega Motion Inc., Travel Pal Four Wheel Scooter, is to provide mobility to persons that have limit id walking capabilities or simply those who wish to ride a scooter for transportation purposes.

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

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

Concurrence of CDRH, Official (Division Sign-Off) Division Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number 11080288