GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54

K063389 · Pride Mobility Products Corp. · INI · Nov 17, 2006 · Physical Medicine

Device Facts

• Record ID: K063389
• Device Name: GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54
• Applicant: Pride Mobility Products Corp.
• Product Code: INI · Physical Medicine
• Decision Date: Nov 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The intended use of the Pride Mobility Products Corp. Go Go Elite Traveller Plus Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also provides a mobility product that transports easily for travel usage.

Device Story

Battery-operated four-wheel scooter; provides mobility for individuals with limited walking capabilities. Features programmable 45-amp 'S' Drive Controller; removable molded plastic seat; foldable tiller; off-board charger. Safety systems include electronic regenerative braking, electromechanical disc brakes, and rear anti-tip wheels. Disassembles into 4 parts (rear section, front section, battery pack, seat) for transport and storage. Operated by user via tiller controls. Provides stable, maneuverable mobility; enhances patient independence and travel convenience.

Clinical Evidence

No clinical data. Bench testing only, including compliance with ANSI/RESNA WC Vol. 1-1998, ANSI/RESNA WC Vol. 2-1998 (including Section 21 for electromagnetic compatibility), IEC 601-1-1, and CAL 117 flammability testing.

Technological Characteristics

Four-wheel motorized scooter; battery-operated; programmable 45-amp 'S' Drive Controller. Features: regenerative/electromechanical disc brakes, rear anti-tip wheels, foldable tiller, modular 4-part disassembly. Materials: molded plastic seat. Standards: ANSI/RESNA WC Vol. 1-1998, ANSI/RESNA WC Vol. 2-1998, IEC 601-1-1, CAL 117.

Indications for Use

Indicated for persons with limited walking capabilities requiring a motorized mobility aid for travel and daily use.

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

• Pride Mobility Sunrunner SC-440 (K930953)

Submission Summary (Full Text)

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K063389

Image /page/0/Picture/1 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, stylized font, with a horizontal line running through the middle of the letters. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller, less bold font. The logo is black and white.

NOV 17 2006

Research & Development 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX [phone] www.pridemobility.com

# Exhibit 1

# 510(k) Summary Pride Mobility Products Corporation Go Go Elite Traveller Plus, Four Wheel Scooter

## Submitter's Name & Address:

Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: [phone] Facsimile: [phone]

## Contact Person:

Thomas Schappert Official Correspondent

## Date Prepared:

10-18-06

#### Name of Device and Proprietary Name:

Go Go Elite Traveller Plus, Four Wheel Scooter / Pride Mobility Products Corporation

#### Common or Usual Name:

Four-Wheel Power Scooter

#### Classification Name:

Physical Medicine / Motorized Three - Wheeled Vehicle

#### Product Code:

INI

#### Comparison to Predicate Devices:

The Go Go Elite Traveller Plus, Four Wheel Scooter is substantially equivalent to the Pride Mobility Sunrunner SC-440 (K930953) when comparing comparits. performance, maneuverability, stability, and structure. The performance characteristics and the position of the electronics and drive mechanisms are similar to achieve the same intended use function that enables the user to maintain optimum stability without hindering performance. The differences between The Sunrunner SC-440 (K930953) and the Go Go Elite Traveller Plus, Four Wheel Scooter is in the overall size, front and rear frame construction, and the Control Mechanisms.

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Image /page/1/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a large, bold, sans-serif font, with a horizontal line running through the middle of the word. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller, sans-serif font. The logo is black and white.

## Device Description:

The Go Go Elite Traveller Plus, Four Wheel Scooter is a compact battery-operated scooter having a programmable 45-amp "S" Drive Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Go Go Elite Traveller Plus, Four Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.

The Go Go Elite Traveller Plus, Four Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is that it can be disassembled into 4 parts: the rear section, the front section, the battery pack, and the seat. This allows for ease of use when traveling or storing the unit.

## Intended Use:

The intended use of the Pride Mobility Products Corp. Go Go Elite Traveller Plus Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also provides a mobility product that transports easily for travel usage.

## Non-Clinical Testing:

Compliance to applicable Testing Standards is as follows:

ANSI/RESNA WC Vol. 1-1998 Requirements and Test Methods for Wheelchairs (Including Scooters)

ANSI/RESNA WC Vol. 2-1998 Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems

ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.

IEC 601-1-1 Medical Electrical Equipment. General Requirements for Safety

CAL 117 - Flammability Testing

# Discussion of Clinical Testing Performed:

N/A

## Conclusions:

The Go Go Elite Traveller Plus, Four Wheel Scooter has the same intended use and similar technological characteristics as the Sunrunner SC-440 (K930953), 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 Go Go Elite Traveller Plus, Four Wheel Scooter is substantially equivalent to the predicate device, has passed all the necessary testing procedures, and is considered to be safe for user operation.

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Public Health Service

Image /page/2/Picture/12 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 image of an eagle with its wings spread.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2006

Pride Mobility Products Corporation % Mr. Thomas Schappert 182 Susquehanna Avenue Exeter, Pennsylvania 18643

Re: K063389

Trade/Device Name: Go Go Elite Traveller Plus/Four Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: ITI Dated: October 18, 2006 Received: November 2, 2006

Dear Mr. Schappert:

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. Thomas Schappert

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 10gally marketed predicate device results in a classification for your device and thus, verroits 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/industry/support/index.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 063389

## Device Name: Go Go Elite Traveller Plus / Four Wheel Scooter

#### Indications for Use:

The intended use of the Pride Mobility Products Corporation Go Go Elite Traveller Plus, Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also provides a mobility product that transports easily for travel usage.

Prescription Use x AND / OR (Part 21 CFR 801 Subpart D)

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) | |
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P.K

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

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510(k) Number k
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3315