V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710

K090805 · Pride Mobility Products Corp. · INI · Apr 3, 2009 · Physical Medicine

Device Facts

• Record ID: K090805
• Device Name: V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710
• Applicant: Pride Mobility Products Corp.
• Product Code: INI · Physical Medicine
• Decision Date: Apr 3, 2009
• 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. V Series Scooters is to provide mobility to disabled persons having limited walking capabilities.

Device Story

V Series Scooters are battery-operated, three or four-wheeled mobility vehicles; intended for disabled persons with limited walking capabilities. Features include programmable controller, removable seat, foldable tiller, two-piece frame, and off-board charger; specific models include power seat actuator. Safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. Device disassembles into four parts (rear section, front section, batteries, seat) for transport/storage. Operated by user via tiller controls; provides mobility to improve patient independence. No clinical data provided.

Clinical Evidence

No clinical data.

Technological Characteristics

Battery-operated motorized scooter; programmable controller; electronic regenerative and electromechanical disc brakes; rear anti-tip wheels. Tested to RESNA WC Vol. 1 & 2 (2008), ANSI/RESNA WC Vol. 2-1998 Section 21 (EMC), IEC 601-1-1 (Safety), and CAL 117 (Flammability).

Indications for Use

Indicated for disabled persons with limited walking capabilities requiring motorized 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

• Victory Three Wheel Scooter (K072165)
• Victory Four Wheel Scooter (K071949)

Submission Summary (Full Text)

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

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

K090805

**Exhibit 1**

# 510(k) Summary Pride Mobility Products Corporation V Series Scooters Three and Four Wheel

APR - 3 2009

## 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:

03-06-09

## Name of Device and Proprietary Name:

V Series Scooters, Three and Four Wheel / Pride Mobility Products Corporation

#### Common or Usual Name:

Three and Four Wheel Power Scooter

#### Classification Name:

Physical Medicine / Motorized Three - Wheeled Vehicle

#### Product Code:

INI

#### Comparison to Predicate Devices:

The V Series Scooters are substantially equivalent to the Pride Mobility, Victory Three Wheel Scooter (K072165) and the Victory Four Wheel Scooter (K071949) when comparing, 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 V Series

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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 stylized font with a thick black outline. Below the word "Pride" is the text "Mobility Products Corp." in a smaller, less stylized font. The logo is black and white.

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

Scooters to the Victory Three Wheel Scooter (K072165) and the Victory Four Wheel Scooter (K071949) are in the motors and control mechanisms.

## Device Description:

The V Series Scooters are three and four wheeled battery-operated scooters. Features include a programmable controller, removable seat, a foldable tiller, two piece frame, and an off board charger; specific models include a Power Seat actuator. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Scooters can be disassembled into four parts: the rear section, the front section, batteries, and the seat; this allows for ease of use when traveling or storing the unit.

The V Series Scooters are designed with ultimate safety, stability, and performance in mind and are designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.

## Intended Use:

The intended use of the Pride Mobility Products Corp. V Series Scooters is to provide mobility to disabled persons having limited walking capabilities.

#### Non-Clinical Testing:

Compliance to applicable Testing Standards is as follows:

RESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters)

RESNA WC Vol. 2 2008 DRAFT - 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 V Series Scooters have the same intended use and similar technological characteristics as the Victory Three Wheel Scooter (K072165) and Victory Four Wheel (K071949), 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 V Series Scooters are substantially equivalent to the predicate devices, have passed all necessary testing, and are considered to be safe for user operation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle faces right and is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR - 3 2009

Re: K090805

Trade Name: V10, Three Wheel Scooter/Model # SC610V

V10, Three Wheel Scooter/Model # SC610VPS with Power Seat

V10, Four Wheel Scooter/Model # SC710V

V10, Four Wheel Scooter/Model # SC710VPS with Power Seat

Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle

Regulatory Class: II Product Code: INI Dated: March 6, 2009

Received: March 25, 2009

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. Iisting 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 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 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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkers 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:

V10, Three Wheel Scooter / Model # SC610V

V10, Three Wheel Scooter / Model # SC610VPS with Power Seat

V10, Four Wheel Scooter / Model # SC710V

V10, Four Wheel Scooter / Model # SC710VPS with Power Seat

#### Indications for Use:

The intended use of the Pride Mobility Products Corporation V Series Scooters is to provide mobility to disabled persons having limited walking capabilities.

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

Over-The-Counter Use × (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) | |
|------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | L040808 |

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