JAZZY 600

K042612 · Pride Mobility Products Corp. · ITI · Oct 6, 2004 · Physical Medicine

Device Facts

• Record ID: K042612
• Device Name: JAZZY 600
• Applicant: Pride Mobility Products Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Oct 6, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Intended Use

The intended use of the Pride Mobility Products Corp. Jazzy 600 Power Wheelchair is to provide mobility to persons limited to a seated position, that have the capability of operating a powered wheelchair.

Device Story

Jazzy 600 is a battery-operated powered wheelchair utilizing Mid-Wheel Drive technology; intended for mobility assistance for individuals limited to a seated position. Device features rigid steel frame, upholstered seat, armrests, drive wheels, rear casters, and front anti-tip casters with nylon spheres to prevent hang-ups. Operated by user via a 75-amp programmable controller; includes electronic regenerative disc brakes, suspension, and onboard battery charger. Used in various environments to provide stability and maneuverability on sloped terrain. Healthcare providers or retailers supply the device to consumers; user operates the wheelchair independently. Benefits include improved mobility and independence for users with physical limitations.

Clinical Evidence

No clinical data. Bench testing only, including compliance with ANSI/RESNA standards for static/dynamic stability, brake effectiveness, dimensions, mass, turning space, static/impact/fatigue strength, climatic tests, obstacle climbing, and electromagnetic compatibility.

Technological Characteristics

Rigid steel frame; Mid-Wheel Drive; 75-amp programmable controller; electronic regenerative disc brakes; suspension; dual motors; two-battery power system. Complies with ANSI/RESNA WC/01, WC/02, WC/03, WC/05, WC/08, WC/09, WC/10, WC/15, WC/93, and CAL 117 flammability standards.

Indications for Use

Indicated for persons limited to a seated position who have the capability of operating a powered wheelchair.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• Pride Mobility Jazzy (K945936)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

JAN 25 2011

Re: K042612

Trade/Device Name: Jazzy 600 Powered Wheelchair Regulation Number: 21 CFR 890. 3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 30, 2004 Received: October 1, 2004

Dear Mr. Schappert:

This letter corrects our substantially equivalent letter of October 6, 2004

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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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# Page 2 - Mr. Thomas Schappert

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Milkeran

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit 3

# Indications for Use

Page __ 1 of of 1 _

# 510(k) Number (if known): K042612

Device Name: Jazzy 600 Powered Wheelchair

Indications For Use:

The intended use of the Pride Mobility Products Corp. Jazzy 600 Powered Wheelchair is to provide mobility to persons limited to a seated position.

Prescription Use × (Per 21 CFR 801 Subpart D)

OR

X 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)

Yong-Hyun Song

(Division Sign-Off) Division of Surgical, Ofthopedic, and Restorative Devices

510(k) Number K042612

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Image /page/3/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", the words "Mobility Products Corp." are written in a smaller, less bold font. The logo is black and white.

OCT 6 - 2004

esearch & Development 330 Philadelphia Avenus est Pittston, PA 18843 570-855-5574 FAX [phone] www.pridemobility.com

> Exhibit 1 092612

# 510(k) Summary Pride Mobility Products Corporation Jazzy 600 Power Wheelchair

# 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:

09-10-04

# Name of Device and Proprietary Name: Jazzy 600 / Pride Mobility

#### Common or Usual Name: Powered Wheelchair Base Unit

#### Classification Name:

Physical Medicine / Wheelchair, Powered

#### Product Code:

ITI

#### Comparison to Predicate Devices:

The Jazzy 600 is substantially equivalent to the Pride Mobility Jazzy (K945936) when comparing performance, maneuverability, stability, dimensions, and geometry. The performance characteristics and the position of the drive mechanisms are similar to achieve the same intended use function that enables the user to maintain optimum stability without hindering performance. Both utilize our patented Mid-Wheel Drive technology, rear casters, and front anti-tip devices for added stability and maneuverability. Key changes between the Jazzy (K945936) and the Jazzy 600 are the replacement of the front anti-tip wheels with front anti-tip casters that have nylon spheres that resist wheel hang-ups. The Jazzy 600 also has side mounted, users accessible freewheel release levers, and front battery access.

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# Device Description:

The Jazzy 600 is a battery-operated power wheelchair featuring Mid-Wheel Drive technology, rear casters, front anti-tip casters, and a standard 75 amp Pride Flight controller. The Jazzy 600 is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.

The Jazzy 600 Power Wheelchair consists of the same basic components found on the Jazzy (K945936), such as a rigid steel frame, upholstered seat, amrests, football drive wheels, rear caster wheels and front anti-tip devices. As a motorized wheelshair substantially equivalent to the Jazzy (K945936) it also offers 2 motors for operational purposes, electronic regenerative disc brakes, suspension, onboard hattery charger, a fully programmable controller, and requires two batteries. Accessories include lap bett, rear basket, cane or crutch holder, oxygen holder, walker holder, flag holder, cup holder, saddle bag, and dust cover.

The Jazzy 600 is designed with ultimate safety, stability, and performance in mind. It features rear casters, and front anti-tip casters which allow for surface contact all times and prevents pitching on sloped terrain.

#### Intended Use:

The intended use of the Pride Mobility Products Corp. Jazzy 600 Power Wheelchair is to provide mobility to persons limited to a seated position, that have the capability of operating a powered wheelchair.

# Non-Clinical Testing:

Compliance to applicable Testing Standards is as follows: 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/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. ANSI/RESNA WC/93 Maximum overall Dimensions CAL 117 - Flammability Testing

# Discussion of Clinical Testing Performed: N/A

# Conclusions:

The Jazzy 600 has the same intended use and similar technological characteristics as the Jazzy (K945936), moreover, the non-clinical testing and the predicate companisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Jazzy 600 is substantially equivalent to the predicate device (Jazzy). The Jazzy 600 has passed all the necessary testing procedures and is considered to be safe for user operation.