Z-CHAIR

K052353 · Pride Mobility Products Corp. · ITI · Sep 9, 2005 · Physical Medicine

Device Facts

• Record ID: K052353
• Device Name: Z-CHAIR
• Applicant: Pride Mobility Products Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Sep 9, 2005
• 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 Z-Chair Powered Wheelchair, is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.

Device Story

Z-Chair is a battery-operated, rear-wheel drive power wheelchair; designed for mobility assistance. Features include 2 motors, electronic regenerative disc brakes, suspension, and off-board battery charger. Key design feature is portability; device disassembles into 4 parts (rear section, front section, battery pack, seat) for transport in vehicle trunks. Operated by the user via a programmable controller. Provides mobility to individuals with physical limitations. Benefits include increased independence and ease of travel due to modular, lightweight design.

Clinical Evidence

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

Technological Characteristics

Battery-operated rear-wheel drive power wheelchair. Features 2 motors, electronic regenerative disc brakes, and suspension. Modular design with single-post, quick-release seat mount. Complies with ANSI/RESNA WC series standards (WC/01, WC/02, WC/03, WC/05, WC/08, WC/09, WC/10, WC/15, WC/93) and CAL 117 flammability standards. Connectivity includes programmable controller.

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 Quantum Blast (K011993)

Submission Summary (Full Text)

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KOS2JS3

SEP - 9 2005

Image /page/0/Picture/1 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 top half 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.

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 Z-Chair 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:

08-02-05

#### Name of Device and Proprietary Name:

Z-Chair / Pride Mobility

### Common or Usual Name:

Powered Wheelchair Base Unit

#### Classification Name:

Physical Medicine / Wheelchair, Powered

## Product Code:

ITI

#### Comparison to Predicate Devices:

The Z-Chair is substantially equivalent to the Pride Mobility Quantum Blast (K011993) when comparing configuration, maneuverability, structure. The performance whor companing companisms 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 rear-wheel drive technology with rear drive wheels, front casters, and rear anti-tip wheels. The key functional change between the Quantum In one out of and the Z-Chair is the Z-Chair's ability to disassemble into four pieces. The reason behind this is to make the product more portable for users who need to travel with the device. The device can essentially be taken apart and loaded into the trunk of a vehicle or stored in a compact space.

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K052353

#### Device Description:

Device Description.
The Z-Chair is a compact battery-operated power wheelchair featuring rear-wheel drive The Z-Chair is a compact battery oportuled power to programmable 50-amp technology, from casters, rear and is the is designed for, but not limited to Pride r enriry & Giles Corp. providers / retailers and their consumers.

As a motorized wheelchair, the Z-Chair offers 2 motors for operational purposes, electronic regenerative disc brakes, suspension, off-board battery charger, a fully electronic regenerative diso brance, battery pack. Accessories include a lap belt, programmable continent cup holder, and zippered accessory pouch.

The Z-Chair is designed with ultimate safety, stability, performance, and portability in The Z-Chair is designed with allinder calbity, than be disassembled into 4 parts the mind. The main feature of the Echants to the seat. This allows for ease of real section, the front section, the battery path, and the shas a lightweight foldable seat, and a single-post, quick-release seat mount.

#### Intended Use:

The intended use of the Pride Mobility Products Corp. Z-Chair Powered Wheelchair is to The intended use of the Pride Mobility 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 Z-Chair has the same intended use and similar technological characteristics as the Quantum Blast (K011993), moreover, the non-clinical testing and the predicate Quarkan - Dido. (10 110 110 110 110 11 their technological characteristics do companions any new questions of safety or effectiveness. Thus, the Z-Chair is not Taloo Jany Tren on the predicate device (Blast). The Z-Chair has passed all the necessary testing procedures and is considered to be safe for user operation.

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized graphic of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle graphic.

SEP - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052353

Trade/Device Name: Z-Chair - Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: August 19, 2005 Received: August 29, 2005

Dear Mr. Schappert:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your 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 for use stated in the encreatives of the enactment date of the Medical Device Amendments, or to conniner of the they 20, 2017 - ) 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 r ou may, aterers, which of the Act include requirements for annual registration, listing of general controls provision 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 may or sabyer is one 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) This letter will and w you to ough finding of substantial equivalence of your device to a legally prematication. The areaults 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 if you deems 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 other general micronational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R. Oyler

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K

Device Name: Z-Chair - Powered Wheelchair

Indications for Use:

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

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

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Concurrence of GDRH, Office of Device Evaluation (ODE) ATTIN NIY (Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_Kos2333

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