QUANTUM BLAST

K011993 · Pride Mobility Products Corp. · ITI · Jul 13, 2001 · Physical Medicine

Device Facts

• Record ID: K011993
• Device Name: QUANTUM BLAST
• Applicant: Pride Mobility Products Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Jul 13, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Intended Use

The intended use of the Quantum Blast is to provide mobility for persons limited to a seated position that are capable of operating a powered wheelchair.

Device Story

Quantum Blast is a rear-wheel drive powered wheelchair; battery-powered and motor-driven. Operated by user via P&G Remote Plus joystick and 100 amp controller. Powered by two 12 VDC Group 24 batteries; range up to 25 miles. Base constructed of welded steel; includes Versa Seat. Used by individuals with mobility limitations to provide independent mobility. Output is physical movement of the chair controlled by user input. No clinical data provided.

Clinical Evidence

No clinical data.

Technological Characteristics

Rear-wheel drive powered wheelchair. Welded steel base. P&G Remote Plus joystick and 100 amp controller. Two 12 VDC Group 24 batteries. Optional seating meets California 117 fire retardancy standards. Tested to ANSI/RESNA WC/01, WC/02, WC/03, WC/05, WC/10, and WC/Vol. 2-1998 standards.

Indications for Use

Indicated for persons limited to a seated position who are capable 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

• SC900 (Jazzy) (K945936)

Submission Summary (Full Text)

{0}------------------------------------------------

K011993

JUL 1 3 2001

# Exhibit 3

### 510 (K) Summary : Pride Mobility Products, Inc. 510 (K) Premarket Notification Quantum Blast

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

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

Contact Person: Gene Kulon Official Correspondent Date Prepared: 05-16-01

Name of Device and Name / Address of Sponsor:

Quantum Blast

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

Common or Usual Name: Four Wheel Power Base Unit

Classification Name: Power Wheel Chair

Comparison to Predicate Devices:

The product, which is substantially equivalent to the Quantum Blast, is the SC900 (Jazzy) (K945936) they both are Joystick controlled, with onboard batteries and battery charger. All safety features are equivalent.

### Device Description:

The Pride Quantum Blast model rear-wheeled drive powered wheelchairs are battery powered, motor driven devices. A P&G Remote Plus joystick and 100 amp controller is used to operate the Quantum Blast. The Quantum Blast is powered by two 12 VDC, Group 24 batteries and has a range of up to 25 miles on a full charge. The base of the chair is made of welded steel

{1}------------------------------------------------

construction. The Quantum Blast comes standard with a Versa Seat. Optional seating material meets California 117 standards for fire retardancy.

Intended Use:

The intended use of the Quantum Blast is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Discussion of non-clinical tests performed for determinations of substantial equivalence are as follows:

ANSI/RESNA WC/01 1990 Determination of Static Stability Testing ANSI/RESNA WC/02 1991 Determination of Dynamic Stability Testing ANSI/RESNA WC/03 1990 Determination of the Effectiveness of brakes ANSI/RESNA WC/05 1990 Determination of overall Dimensions, Mass, and Turning Space ANSI/RESNA WC/10 1990 Determination of Obstacle Climbing Ability ANSI/RESNA WC/Vol. 2-1998 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters.

Discussion of Clinical Tests Performed:

N/A

Conclusions:

The Quantum Blast has the same intended use and similar technological characteristics as the Jazzy SC-900. 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 Quantum Blast device is substantially equivalent to the predicate device. All software used on the Quantum Blast is Y2K Compliant.

Discussion of Clinical Tests Performed:

N/A

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, representing the department's focus on health and human well-being.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 3 2001

Mr. Gene R. Kulon Regulatory Compliance Officer Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pennsylvania 18643

Re: K011993

Trade/Device Name: Quantum Blast, Powered Wheelchair Regulation Number: 890.3860 Regulatory Class: II Product Code: ITI Dated: June 22, 2001 Received: June 26, 2001

Dear Mr. Kulon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Mr. Gene R. Kulon

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Hyk Rhodes

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## EXHIBIT 2

Page _ 1 of 1

# 510(k) Number (if known): K- O / / 9 93

Quantum Blast, Powered Wheelchair Device Name:

### Indications for Use:

The intended use of the Quantum Blast is to provide mobility for persons limited to a seated position that are capable of operating a powered wheelchair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hyet Riode

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K011993

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96) *