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510(k) Data Aggregation

    K Number
    K080288
    Device Name
    TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114
    Manufacturer
    MEGA MOTION, INC.
    Date Cleared
    2008-02-15

    (11 days)

    Product Code
    INI, CLA
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEGA MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 Description
    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.
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    K Number
    K060697
    Device Name
    TRAVEL PAL (MM-111B) /MEGA MOTION
    Manufacturer
    MEGA MOTION, INC.
    Date Cleared
    2006-04-11

    (26 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEGA MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 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.
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    K Number
    K982144
    Device Name
    MEGA 4
    Manufacturer
    MEGA MOTION, INC.
    Date Cleared
    1999-04-14

    (301 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEGA MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mega 4 scooter is intended to help the user achieve a more independent lifestyle by increasing their personal mobility. The Mega 4 is intended for use by people who due to medical reasons, accident, or injury do not have adequate mobility to lead the active lifestyle they want. It is also intended for any person who would simply rather ride a scooter than walk.
    Device Description
    The Mega 4 is a four-wheel power scooter designed to help people with poor mobility lead a more active lifestyle. The fact that this is a 4-wheel scooter with a two wheel front end provides for a very stable ride. The Mega 4 scooter is an ideal outdoor scooter capable of traversing bumpy or uneven terrain. The Mega 4 is a four-wheel scooter with exceptional handling and is quiet due to the use of pneumatic tires and a sealed transaxle as opposed to a separate motor, differential, and chain application. It is equipped with two kinds of brakes: dynamic regenerative and a parking brake. The electronic parking brake is normally on and is released when the driver moves the throttle lever. When the driver releases the throttle lever, the regenerative braking will slow the scooter to a stop and the parking brake will be activated 1/2 second thereafter, holding the scooter, preventing any movement. The electronic controller of the Mega 4 has a water-resistant casing with no exposed wires. This feature protects the electronics from environmental damage and corrosion. The Mega 4 Scooter's maximum forward speed is 5.0mph. The maximum speed in reverse is 60% of the maximum forward speed or 3.0mph. The speed in reverse is reduced for safety purposes as it is more difficult to negotiate a scooter in reverse motion than in forward motion. The speeds are regulated by two devices: a throttle lever and a speed potentiometer. The Mega 4 has several user-friendly features. It comes equipped with an external freewheeling release lever, external battery charger jack, and an external circuit breaker reset button all for easy accessibility. It has a special light-weight-seat (21 lbs.) for easy disassembly and transportation. The seat is adjustable up and down, swivels 360°, and has flip up arms. The Mega 4 is equipped with two lateral and two rear high visibility reflectors to increase the scooter's visibility. This feature, as well as the anti-tip wheels located 1 ¼" from the ground on the rear of the scooter, provide added safety for the passenger. The Mega 4 has an adjustable tiller for user comfort and easy transportation. The Mega 4 scooter has an on board charger as standard equipment. The Mega 4 uses two 12-Volt 31 Amp sealed lead acid batteries.
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    K Number
    K982145
    Device Name
    MEGA 3
    Manufacturer
    MEGA MOTION, INC.
    Date Cleared
    1999-04-14

    (301 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEGA MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mega 3 scooter is intended to help the user achieve a more independent lifestyle by increasing their personal mobility. The Mega 3 scooter is intended for use by people who due to medical reasons, accident, or injury do not have adequate mobility to lead the active lifestyle they want. It is also intended for any person who would simply rather ride a scooter than walk.
    Device Description
    The Mega 3 is a three-wheel power scooter designed to help people with poor mobility lead a more active lifestyle. The fact that this is a 3-wheel scooter with a sharp turning radius makes it ideal for indoor use and cornering in close quarters. The Mega 3 scooter is also ideal for outdoor use as it is capable of traversing bumpy or uneven terrain. The Mega 3 is a three-wheel scooter with exceptional handling and is quiet due to the use of pneumatic tires and a sealed transaxle as opposed to a separate motor, differential, and chain application. It is equipped with two kinds of brakes: dynamic regenerative and a parking brake. The electronic parking brake is normally on and is released when the driver moves the throttle lever. When the driver releases the throttle lever, the regenerative braking will slow the scooter to a stop and the parking brake will be activated 1/2 second thereafter, holding the scooter, preventing any movement. The electronic controller of the Mega 3 has a water-resistant casing with no exposed wires. This feature protects the electronics from environmental damage and corrosion. The Mega 3 Scooter's maximum forward speed is 5.0mph. The maximum speed in reverse is 60% of the maximum forward speed or 3.0mph. The speed in reverse is reduced for safety purposes as it is more difficult to negotiate a scooter in reverse motion than in forward motion. The speeds are regulated in two ways: a throttle lever and a speed potentiometer. The Mega 3 has several user-friendly features. It comes equipped with an external freewheeling release lever, external battery charger jack, and an external circuit breaker reset button all for easy accessibility. It has a special light-weight-seat (21 lbs.) for easy disassembly and transportation. The seat is adjustable up and down, swivels 360°, and has flip up arms. The Mega 3 is equipped with two lateral and two rear high visibility reflectors to increase the scooter's visibility. This feature, as well as the anti-tip wheels located 1 1/2" from the ground on the rear of the scooter, provide added safety for the passenger. The Mega 3 has an adjustable tiller for user comfort and easy transportation. The Mega 3 scooter has an on board charger as standard equipment. The charger has passed the minimum voltage ground leakage as required by the FDA/U.L. Certification from the charger supplier is included in section 4 of the 510(k)-application package. The Mega 3 uses two 12-Volt 31 Amp sealed lead acid batteries. Certifications from the battery supplier that the batteries used on the Mega 3 meet the requirements of 49CFR173.159(d) and Special Provision A67 of the IATA Dangerous Goods Regulations for non-spillable batteries and are therefore, unrestricted for transportation by any means are enclosed in section 4 of this 510(k)-application package.
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