QUANTUM BARIATRIC 451

K112815 · Pride Mobility Product Corporration · ITI · Feb 29, 2012 · Physical Medicine

Device Facts

• Record ID: K112815
• Device Name: QUANTUM BARIATRIC 451
• Applicant: Pride Mobility Product Corporration
• Product Code: ITI · Physical Medicine
• Decision Date: Feb 29, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Indications for Use

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

Device Story

Quantum Bariatric 451 is a powered wheelchair for mobility-impaired users. Components include digital controller, electrical system, motors, batteries, seating, frame, electronic regenerative disc brakes, 8A off-board charger, front anti-tip wheels, and rear casters. Operated by user via digital controller. Provides mobility for individuals capable of operating the device. Designed for safety, stability, and performance. Supports higher weight capacity (600 lbs) and larger dimensions compared to predicate.

Clinical Evidence

No clinical data. Bench testing only, including RESNA WC Vol. 1 & 2 (2009), ANSI/RESNA WC Vol. 2-2008 Section 21 (EMC), CAL 117 (flammability), BS EN1021 (ignitability), and ISO 10993 (biocompatibility).

Technological Characteristics

Powered wheelchair with digital controller, electrical system, motors, and batteries. Features electronic regenerative disc brakes, 8A off-board charger, front anti-tip wheels, and rear casters. Tested to RESNA WC Vol. 1/2, ANSI/RESNA WC Vol. 2-2008, CAL 117, BS EN1021, and ISO 10993 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 Frontie (K092961)

Submission Summary (Full Text)

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K112815

FEB 2 9 2012

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

# Exhibit 1 510(k) Summary Pride Mobility Products Corporation Quantum Bariatric 451

### Submitter's Name & Address:

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

### Contact Person:

Kimberly Blake

### Date Updated:

12/12/2011

Name of Device and Proprietary Name: Quantum Bariatric 451

Common or Usual Name: Powered Wheelchair

### Classification Name:

Physical Medicine / Powered Wheelchair

# Product Code:

ITI

# Comparison to Predicate Devices:

The Quantum Bariatric 451 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. Please refer to Exhibits 4A, 7, 7A, and additional information provided for comparisons and testing data.

The major differences between the Quantum Bariatric 451 and the Jazzy Frontie (K092961) are in the weight capacity, drive wheels, and dimensions:

- Jazzy Frontie weight capacity is 300 lbs versus 600 lbs for the Bariatric . 451.
FDA/1400-5 Rev. 0 Date: 4/23/10 App'd: K. Blake

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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 registered trademark symbol next to it. Below "Pride" is the text "Mobility Products Corp."

- Jazzy Frontie has 9" drive wheels versus 14" on the Bariatric 451. �
- Jazzy Frontie is smaller dimensionally (34.75" L and 22.75" W) versus . the larger Bariatric 451 (46.6" L, 29" W).

### Device Description:

The Quantum Bariatric 451 is a Powered Wheelchair having a digital controller, electrical system, motors, batteries, seating, and frame. The Quantum Bariatric 451 is equipped with electronic regenerative disc brakes, 8A off-board battery charger, removable 12 volt batteries, front anti-tip wheels, and rear caster wheels.

The Quantum Bariatric 451 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 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 (Refer to 7F for FDA-3654): 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

BS EN1021- Furniture - Assessment of the Ignitability of Upholstered Furniture, Part 2 ISO 10993 -Biological evaluation of medical devices

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

### Conclusions:

The Quantum Bariatric 451 Powered Wheelchair has the same intended use and similar technological characteristics as the Jazzy Frontie (K092961), 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 Quantum Bariatric 451 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right, and its wings are curved upwards. The logo is simple and clean, and it is easily recognizable.

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

Pride Mobility Products Corporation % Ms. Kimberly Blake 182 Susquehanna Avenue Exeter, Pennsylvania 18643

FEB 2 9 2012

Re: K112815

Trade/Device Name: Quantum Bariatric 451 Regulation Number: 21 CFR 890. Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 3, 2012 Received: February 3, 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 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.

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### Page 2 - Ms. Kimberly Blake

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you uesire specific advice tor your downters/CDRHOffices/ucm115809.htm for go to mtb.//www.ida.gov//rbout/Drical Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and readorogies. In a lease to premarket notification" (21CFR Part note the regulation childed, "Misolanding of corrects 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 Tou may obtain other general mionnations one Jone 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 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 registered trademark symbol next to the "e". Below the word "Pride" is the text "Mobility Products Corp." in a smaller, sans-serif font.

# Exhibit 3

# Indications for Use

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

Device Name: Quantum Bariatric 451

Indications for Use: The intended use of the Pride Mobility Products Indications "Tor" OSC." The "MC1 is to provide mobility to persons limited to a Corporation Quantain Banather 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)

> Evaluation (ODE) Concurrence of CDRH, Office of

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112815