(167 days)
Not Found
No
The description focuses on standard powered mobility technology using a joystick controller, motors, and batteries, with no mention of AI or ML capabilities.
No
Explanation: The device is described as a mobility aid for persons restricted to a prone position, similar to a power wheelchair or gurney, rather than providing or supporting a medical treatment for a disease or condition.
No
Explanation: The device is described as providing mobility and transportation to individuals in a prone position, similar to a power wheelchair or gurney. Its functions relate to movement and patient support, not the diagnosis of a medical condition.
No
The device description clearly outlines hardware components such as a battery, motor, wheeled frame, steel construction, and a joystick controller. While it uses a controller, the core functionality and description are centered around a physical, powered gurney.
Based on the provided information, the Ability Power Gurney is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Ability Power Gurney's Function: The description clearly states the device's purpose is to provide mobility and transportation to individuals who are limited to a prone position and can operate a powered wheelchair. It's a physical mobility aid.
- Lack of Diagnostic Activity: There is no mention of the device analyzing biological samples, performing tests, or providing diagnostic information about a patient's health status.
The device is a medical device, but it falls under the category of a mobility aid or transport device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
ITI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Safety 1: Safety Requirements for Medical Electrical Systems
IEC 601-1-2 Medical Electrical Equipment- Part 1: General Requirements for Safety 2: Electromagnetic Capability- Requirements and Tests
UL 2601-1 Standard for Medical Electrical Equipment-Part 1: General Requirements for Safety
CAN/CSA-C22.2 No. SD1.1-M90, Medical Electrical Equipment Part 1: General Requirements for Safety
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 890.3860 Powered wheelchair.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
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
Safety 1: Safety Requirements for Medical Electrical Systems |
|---------------|--------------------------------------------------------------------------------------------------------------------------------|
| IEC 601-1-2 | Medical Electrical Equipment- Part 1: General Requirements for
Safety 2: Electromagnetic Capability- Requirements and Tests |
| UL 2601-1 | Standard for Medical Electrical Equipment-Part 1: General
Requirements for Safety |
| CAN/CSA-C22.2 | No. SD1.1-M90, Medical Electrical Equipment Part 1: General
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
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