TRAVEL PAL (MM-111B) /MEGA MOTION

K060697 · Mega Motion, Inc. · INI · Apr 11, 2006 · Physical Medicine

Device Facts

• Record ID: K060697
• Device Name: TRAVEL PAL (MM-111B) /MEGA MOTION
• Applicant: Mega Motion, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Apr 11, 2006
• 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 Powered 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

Travel Pal is a battery-operated 3-wheel power scooter for mobility assistance. Features include rear anti-tip wheels, digital controller, foldable tiller, electronic regenerative disc brakes, and removable batteries. Designed for portability with a lightweight, foldable, removable seat. Operated by the user for personal transportation. Provides mobility for individuals with limited walking capabilities. Substantially equivalent to Mega3 (K982145) in configuration, maneuverability, and stability; utilizes rear-drive mechanism.

Clinical Evidence

No clinical data. Bench testing only, including compliance with ANSI/RESNA standards for dimensions, static/dynamic stability, brake effectiveness, energy consumption, obstacle climbing, electromagnetic compatibility, and flammability (CAL 117).

Technological Characteristics

Battery-operated 3-wheel scooter. Features: digital controller, electronic regenerative disc brakes, removable batteries, foldable tiller, and seat. Tested to ANSI/RESNA WC series standards (static/dynamic stability, braking, energy, dimensions, fatigue, obstacle climbing) and electromagnetic compatibility. Flammability tested per CAL 117.

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

• Mega3, MM-333 (K982145)

Submission Summary (Full Text)

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# Travel Pal 510(k) Summary

Submitter's Name & Address:

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

Mark Calomino Official Correspondent

Date Prepared:

Contact Person:

Name of Device and Proprietary Name:

Common or Usual Name:

Classification Name:

03-02-06

Travel Pal (MM-111B) / Mega Motion

3-Wheel Power Scooter

Vehicle, Motorized 3-Wheeled

Product Code:

INI

## Device Description:

The Travel Pal is a compact battery-operated Three Wheel power Scooter featuring rear anti-tip wheels, a standard digital controller, and a foldable tiller. The Travel Pal is designed for, but not limited to Mega Motion, Inc. providers / retailers and their consumers.

As a motorized Scooter, the Travel Pal offers economical mobility, and is equipped with; electronic regenerative disc brakes, off-board battery charger, and removable batteries. Accessories include a front basket.

The Travel Pal is designed with ultimate safety, stability, performance, and portability in mind. The product also has a lightweight, foldable seat, which is removable and allows for ease of portability when traveling or storing the unit.

## Comparison to Predicate Devices:

The Travel Pal is substantially equivalent to Mega Motion, Inc. Mega3, MM-333 (K982145) when comparing configuration, maneuverability, stability, and structure. The performance characteristics and the position of the drive mechanisms are similar to achieve the same intended use function that enables

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the user to maintain optimum stability without hindering performance. Both utilize rear drive and rear anti-tip wheels. The key functional change between the Mega3 and the Travel Pal is the Travel Pal's frame is one piece, and batteries are accessible by shroud removal.

#### Intended Use:

The intended use of the Mega Motion, Inc, Travel Pal Powered 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/93 Maximum Overall Dimensions 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/15 Documentation and Labeling ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility. CAL 117 - Flammability Testing

#### Discussion of Clinical Testing Performed:

N/A

#### Conclusions:

The Travel Pal has the same intended use and similar technological characteristics as the Mega3 (K982145), 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 is substantially equivalent to the predicate device (Mega 3 MM333). The Travel Pal has passed all the necessary testing procedures and is considered to be safe for user operation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1 2006

Mega Motion, Inc. c/o Mr. Mark Calomino 957 Wood Street Old Forge, Pennsylvania 18518

Re: K060697

Trade/Device Name: Travel Pal - 3 Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: March 6, 2006 Received: March 16, 2006

Dear Mr. Calomino:

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. Mark Calomino

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,

Mark N. Melkerson

- 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 - 3 Wheel Scooter

#### Indications for Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OMDI

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

510(k) Number_ko60697