ABILITY POWER GURNEY

{0}------------------------------------------------ #### 510(k) SUMMARY K042699 MAR 1 6 2005 Gator Custom Mobility, Inc. 510 (k) Premarket Notification Power Gurney #### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared: Gator Custoni Mobility, Inc. 501 NE 23td Ave. Gainesville, I'L 32609 Phone: (352) 373-9673 Fax: (352) 271-9070 Contact Person: Gregory S. Sims Vice President Date Propared: September 8, 2004 #### Name of Device and Name/Address of Sponsor: Ability Power Gurney Gator Custom Mobility, Inc. 501 NE 23td Ave. Gainesville, FL 32609 Phone: (352) 373-9673 Fax: (352) 271-9070 ### Common or Usual Name: Powered Wheeled Stretcher Classification Name: Powered Wheeled Stretcher Regulatory Class: Class II ### Predicate Devices: Products that are substantially equivalent to the Ability Power Gurney are the Stryker Powered Wheeled Stretcher (K022309, August 13, 2002) and the Invacare Storm Series power wheelchair (K993413, October 12, 1999) #### Intended Use: The intended use of the Ability Power Gurney is to provide mobility to persons limited to a prone position, that have the capability of operating a powered wheelchair {1}------------------------------------------------ ## Technological Characteristics and Substantial Equivalence ## A. Device Description The Ability Power Gurney is a battery powered, motor driven device consisting of a platform mounted on a wheeled frame that is designed to provide mobility and transportation to physically challenged persons that may be restricted to a horizontal position. The device may have patient securement straps and supports for fluid infusion equipment. A Penny and Giles VSI controller joystick and a 70amp controller is used to operate the Ability Power Gurney, the same as the predicate device, the Invacare Storm Power Wheelchair. The Ability Power Gurney is powered by two 12VDC, Group U-1 Gel Batteries and has a range of up to 15 miles on a full charge. The base of the stretcher is made of welded steel construction. The Ability Power Gurney and the predicate both have a caster mounted design with a variable height top surface. The top may be controlled by the client for pressure relief and access to different heights. Optional material meets California 117 standards for fire retardancy. ## B. Substantial Equivalence Products which are substantially equivalent to the Ability Power Gurney are the Stryker Powered Wheeled Stretcher (K022309, August 13, 2002) and the Invacare Storm Series power wheelchair (K993413, October 12, 1999) ### Performance Data The motors and control mechanisms for the Ability Power Gurney, the same that are on the Invacare Storm power wheelchair, meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176:1993 (E) "ISO Standard, Wheelchairs-Requirments and Test Methods for the Power and Control Systems of Electric Wheelchairs. The Ability Power Gurney will comply with the following voluntary standards: | IEC 601-1-1 | Medical Electrical Equipment- Part 1: General Requirements for<br>Safety 1: Safety Requirements for Medical Electrical Systems | |---------------|--------------------------------------------------------------------------------------------------------------------------------| | IEC 601-1-2 | Medical Electrical Equipment- Part 1: General Requirements for<br>Safety 2: Electromagnetic Capability- Requirements and Tests | | UL 2601-1 | Standard for Medical Electrical Equipment-Part 1: General<br>Requirements for Safety | | CAN/CSA-C22.2 | No. SD1.1-M90, Medical Electrical Equipment Part 1: General<br>Requirements for Safety | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. The seal is in black and white. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 16 2005 Mr. Gregory S. Sims Vice President Gator Custom Mobility, Inc. 501 NE 22RD Avenue Gainesville, Florida 32609 Re: K042699 Trade/Device Name: Ability Power Gurney Regulation Numbers: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Codes: ITI Dated: March 9, 2005 Received: March 11, 2005 Dear Mr. Sims: We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above und nave acteming ally marketed predicate devices marketed in interstate 10 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner to May 20, 1978) in accordance with the provisions of the Federal Food, Drug, devices that have occh receasined in assess as a proval 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, merore, mains of the Act include requirements for annual registration, listing of general controlo provider ing 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 If your device is exassined controls. Existing major regulations affecting your device can may be subject to back at 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 r lease be advisod that i bring that your device complies with other requirements of the Act that I Dr. Has intess and regulations administered by other Federal agencies. You must or any I edetal the Act's requirements, including, but not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of N Fart 007), its ensterns (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. {3}------------------------------------------------ Page 2 -- Mr. Gregory S. Sims This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and will and organ mains of substantial equivalence of your device to a legally premailted 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), please If you desire specific acrio ior you (240) 276-0120. Also, please note the regulation entitled, Colliabl the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely yours, Sincerely yours, Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K042699 Device Name: Abili rower Gurney Indications For Use: The indication for use of the Ability Power Gurney is to provide mobility to persons limited to a prone position, that have the capability of operating a powered wheelchair. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpert C) (PLEASE DO NOT WRITE BELOW THIS I.INE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General Destorative, and Neurological Devices 510(k) Number K042699 Page of