JAZZY ELITE 6

K113488 · Pride Mobility Product Corporration · ITI · Apr 18, 2012 · Physical Medicine

Device Facts

• Record ID: K113488
• Device Name: JAZZY ELITE 6
• Applicant: Pride Mobility Product Corporration
• Product Code: ITI · Physical Medicine
• Decision Date: Apr 18, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Intended Use

The intended use of the Pride Mobility Products Corporation device is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.

Device Story

Jazzy Elite 6 is a powered wheelchair featuring a digital controller, electrical system, motors, batteries, seating, and frame. It utilizes electronic regenerative disc brakes, 3A off-board battery charger, removable 12-volt batteries, drive wheels, and six ground-contact wheels (including front caster wheels). Operated by the user via a digital controller to provide mobility for individuals limited to a seated position. Designed for use by consumers; distributed through providers/retailers. Output is physical mobility; device enhances patient independence. No clinical data provided; safety and performance verified through bench testing.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including compliance with RESNA WC Vol. 1 2009, RESNA WC Vol. 2 2009, ANSI/RESNA WC Vol. 2-2008 Section 21 (EMC), CAL 117 (flammability), and ISO 10993 (biocompatibility).

Technological Characteristics

Powered wheelchair with digital controller, electrical system, motors, and batteries. Features six-wheel configuration with 5" front caster wheels. Complies with RESNA WC Vol. 1 & 2 (2009), ANSI/RESNA WC Vol. 2-2008 Section 21, CAL 117, and ISO 10993. Includes electronic regenerative disc brakes and 3A off-board battery charger.

Indications for Use

Indicated for persons limited to a seated position who possess the capability to operate 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 Frontie (K092961)

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 bold, italicized font, with a registered trademark symbol next to the "e". Below the word "Pride" is the text "Mobility Products Corp." in a smaller, non-italicized font.

APR 1 8 2012

AGE 10 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX [phone]

KII3489

## Exhibit 1 510(k) Summary Pride Mobility Products Corporation Jazzv Elite 6

### Submitter's Name & Address:

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

### Contact Person:

Kimberly Blake

Date Prepared: 11/18/2011

Name of Device and Proprietary Name: Jazzy Elite 6

Common or Usual Name: Powered Wheelchair

### Classification Name:

Physical Medicine / Powered Wheelchair

### Product Code:

ITI

### Comparison to Predicate Devices:

The Jazzy Elite 6 is substantially equivalent to the Pride Mobility Jazzy Frontie (K092961), 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. Refer to Exhibit 7 for verification and validation activities.

The major differences between the Jazzy Elite 6 and the Jazzy Frontie (K092961) are in the front wheels. The Jazzy Frontie (K092961) has four (4) wheels on the ground while the Jazzy Elite 6 has six (6) wheels on the ground:

- Jazzy Frontie (K092961) utilizes 3" front anti-tip wheels (off of the ground) . versus the Jazzy Elite 6 which utilizes 5" front caster wheels (on the ground).

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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, sans-serif font, with the "i" dotted with a registered trademark symbol. Below "Pride" is the text "Mobility Products Corp." in a smaller, sans-serif font. The logo is black and white.

KIT3488 AGE 2 OF 2 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX [phone]

### Device Description:

The Jazzy Elite 6 is a Powered Wheelchair having a digital controller, electrical system, motors, batteries, seating, and frame. The Jazzy Elite 6 is equipped with electronic regenerative disc brakes, 3A off-board battery charger, removable 12 volt batteries, drive wheels, and front and rear caster wheels.

The Jazzy Elite 6 is designed with ultimate safety, stability, and performance in mind. The Powered Wheelchair is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.

#### Intended Use:

The intended use of the Pride Mobility Products Corporation device 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 (See 7F for FDA-3654 forms): RESNA WC Vol.1 2009 - Requirements and Test Methods for Wheelchairs (Including Scooters) RESNA WC Vol. 2 2009 - Additional Requirements for Wheelchairs (Including Scooters)

with Electrical Systems ANSI/RESNA WC Vol. 2-2008 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.

CAL 117 - Flammability Testing

ISO 10993 -Biocompatibility Testing

### Discussion of Clinical Testing Performed:

N/A

#### Conclusions:

The Jazzy Elite 6 Powered Wheelchair has the same intended use and similar technological characteristics as the Jazzy Frontie (K092961), 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 Jazzy Elite 6 is substantially equivalent to the predicate device, has passed all the necessary testing, 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

#### Public Health Service

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

# APR 1 8 2012

Pride Mobility Product Corporation % Ms. Kimberly Blake Assistant Manger, Regulatory QA-Regulatory Compliance 182 Susquehanna Avenue Exeter. Pennsylvania 18643

Re: K113488

Trade/Device Name: Jazzy Elite 6 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 19, 2012 Received: March 19, 2012

#### Dear Ms. Blake:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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#### Page 2 - Ms. Kimberly Blake

device-related adverse events) (21 CFR 803); 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.

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,

Eunel Keith

´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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Image /page/4/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, sans-serif font, with the letters slightly overlapping. Below "Pride" is the text "Mobility Products Corp." in a smaller, sans-serif font. The logo is black and white.

..

182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX [phone]

### Exhibit 3

# Indications for Use

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

Device Name: Jazzy Elite 6

Indications for Use: The intended use of the Pride Mobility Products Corporation device is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.

#### Prescription Use X (Part 21 CFR 801 Subpart D)

AND / OR

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)

(Div) Rick -Off Sigh Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113488