VICTORY THREE WHEEL SCOOTER, MODEL: SC610

K072165 · Pride Mobility Products Corp. · INI · Aug 17, 2007 · Physical Medicine

Device Facts

• Record ID: K072165
• Device Name: VICTORY THREE WHEEL SCOOTER, MODEL: SC610
• Applicant: Pride Mobility Products Corp.
• Product Code: INI · Physical Medicine
• Decision Date: Aug 17, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Pride Mobility Products Corp. Victory Three Wheel Scooter is to provide mobility to persons having limited walking capabilities.

Device Story

Battery-operated three-wheel scooter; provides mobility for individuals with limited walking capabilities. Features include programmable 70-amp digital controller, removable molded plastic seat, foldable tiller, and off-board charger. Safety mechanisms include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. Narrow 22-inch wheelbase enhances maneuverability. Operated by the user; intended for use in various environments to assist with personal mobility. Output is physical transport of the user; healthcare providers use the device to improve patient mobility and independence.

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 EMC), IEC 60335-2-29, IEC 601-1-1, and CAL 117 flammability testing.

Technological Characteristics

Battery-operated motorized three-wheeled vehicle. Features a programmable 70-amp digital controller. Construction includes molded plastic seat and metal frame. Safety systems: electronic regenerative and electromechanical disc brakes, rear anti-tip wheels. 22-inch wheelbase. Complies with ANSI/RESNA WC Vol. 1-1998, ANSI/RESNA WC Vol. 2-1998, IEC 60335-2-29, and IEC 601-1-1 standards.

Indications for Use

Indicated for persons with limited walking capabilities requiring mobility assistance.

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 SC300 (K926295)

Submission Summary (Full Text)

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K072/65

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 Victory Three Wheel Scooter

## Submitter's Name & Address:

AUG 17 2007

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

## Contact Person:

Thomas Schappert Official Correspondent

Date Prepared:

08-03-07

#### Name of Device and Proprietary Name:

Victory Three Wheel Scooter / Pride Mobility Products Corporation

## Common or Usual Name:

Three-Wheel Power Scooter

## Classification Name:

Physical Medicine / Motorized Three - Wheeled Vehicle

## Product Code:

INI

## Comparison to Predicate Devices:

The Victory Three Wheel Scooter is substantially equivalent to the Pride Mobility SC300 (K926295) when comparing components, performance, Legend 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 Legend SC300 (K926295) and the Victory Three Wheel Scooter are in the wheelbase, 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 bold, stylized font with a horizontal line running through the middle of the letters. Below the word "Pride" is the text "Mobility Products Corp." in a smaller, less bold font. The logo appears to be slightly distressed or textured.

#### Device Description:

The Victory Three Wheel Scooter is a mid-size battery-operated scooter having a programmable 70-amp Digital Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic reqenerative and electromechanical disc brakes, and rear anti-tip wheels. The Victory Three Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.

The Victory Three Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is a narrow wheelbase (22"), which allows better maneuverability from a mid-sized product.

#### Intended Use:

The intended use of the Pride Mobility Products Corp. Victory Three Wheel Scooter is to provide mobility to persons having limited walking capabilities.

#### 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 60335-2-29 Safety of Electrical Appliances (Part 2 Battery Chargers) IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety CAL 117 - Flammability Testing

#### Discussion of Clinical Testing Performed: N/A

#### Conclusions:

The Victory Three Wheel Scooter has the same intended use and similar technological characteristics as the Legend SC300 (K926295), moreover, the nonclinical 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 Victory Three Wheel Scooter is substantially equivalent to the predicate device, has passed all testing requirements, and is considered to be safe for user operation.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized emblem. The emblem is a representation of a human figure, with three lines forming the body and head, and two lines forming the legs.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pride Mobility Products Corporation % Mr. Thomas Schappert Official Correspondent 182 Susquehanna Avenue Exeter, PA 18643

AUG 1 7 2007

Re: K072165

Trade/Device Name: Victory Three Wheel Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: August 3, 2007 Received: August 6, 2007

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 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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Xanthum

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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# Exhibit 3

## Indications for Use

## 510(k) Number (if known): K

## Device Name: Victory Three Wheel Scooter SC610

#### Indications for Use:

The intended use of the Pride Mobility Products Corporation Victory Three Wheel Scooter, is to provide mobility to persons having limited walking capabilities.

| 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)

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices

510(k) Number / L072165

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