(115 days)
No
The device description and performance studies focus on standard mechanical and electrical components and testing for powered wheelchairs, with no mention of AI or ML technologies.
No.
The device is a power wheelchair, designed to provide mobility for individuals limited to a sitting position, not to treat or cure a medical condition.
No
The device description clearly states it is a power wheelchair, designed to provide mobility, and there is no mention of it being used to diagnose any medical conditions.
No
The device description clearly outlines physical hardware components such as batteries, motors, gearboxes, wheels, casters, and a joystick controller, indicating it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to provide mobility to individuals with limited sitting ability who can operate a powered wheelchair. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered wheelchair, its components (motors, batteries, frame, seating), and how it provides mobility. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The device is clearly a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The intended use of the Invacare Action Storm and Ranger II Front Wheel Drive Power Wheelchairs is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
To provide mobility to persons limited to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Invacare Models Ranger II and Power 9000 front wheel drive power wheelchairs are battery powered, motor driven devices with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. They are non rigid, or "folding" type, front wheel drive power wheelchairs.
The wheelchairs are controlled using the Invacare Model MCC-MKIV RII Motor Controller and Joystick. They are powered by two Size 22NF 12 VDC batteries. Access to the batteries is gained from underneath the chairs will travel approximately 17 to 22 miles between charges, depending on use.
The wheelchairs consist of two basic sub-sections. These are the base section of the wheelchair, and the seating section of the wheelchair. Both are of welded steel construction. The base section includes the base frame, front drive wheels and axles, rear pivoting casters, motor/gearbox drive mechanism and batteries. The motor/gearbox location is adjustable, relative to the upper seating frame. This adjustment is used to compensate for weight and balance shift, which are both user dependent.
The seating, or upper section of the wheelchair, includes the seating upholstery, front foot rests, side arm rests, and joystick operating control. Seating sizes range from 14" wide to 20" wide, depending on user needs. The wheelchair motor controller is mounted to the side arm and under the backrest of the seat. The upholstery material is fabricated from either U240 Nylon, or reinforced vinyl, depending upon the user's preference. Both of these materials meet California 117 and Boston Fire Department BFD-1 specifications 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)
As required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three- Wheeled Vehicles", the Invacare Action Storm and Ranger II Front Wheel Drive Power Wheelchairs were tested in accordance with ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995) for powered wheelchairs and motorized scooters. In all instances, the Invacare Action Storm and Ranger II Front Wheel Drive Power Wheelchairs met the required performance criteria and functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
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文 1 P Sac Fifth
510(k) SUMMARY
Invacare Corporation's
Models Action Storm Ranger II and Power 9000 Front Wheel Drive Power Wheelchairs
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation One Invacare Way PO Box 4028 Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Contact Person:
. ............................................................................................................................................................................
Edward A. Kroll Director, TQM and Regulatory Affairs
Date Prepared:
June 10, 1998
Name of Device and Name/Address of Sponsor
Models Action Storm Ranger II and Action Storm Power 9000 Power Wheelchairs
Invacare Corporation One Invacare Way Elyria, Ohio 44036-2028 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Common or Usual Name
Power Wheelchair
Classification Name
Wheelchair, Powered
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Predicate Devices
The Models Ranger II and Power 9000 Front Wheel Drive power wheelchairs are substantially equivalent to Permobil's Chairman (K960951, April 4, 1997) Front Wheel Drive Power Wheelchair and Invacare Power 9000 (K900565, February 2, 1990) power wheelchairs. The wheelchairs are controlled using the Invacare Model MCC-MKIV RII Motor Controller and Joystick. This controller was granted marketing clearance by FDA on June 2, 1994, under 510(k) Accession Number K940972.
Intended Use
The intended use of the Invacare Action Storm and Ranger II Front Wheel Drive Power Wheelchairs is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
Technological Characteristics and Substantial Equivalence
A. Device Description
The Invacare Models Ranger II and Power 9000 front wheel drive power wheelchairs are battery powered, motor driven devices with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. They are non rigid, or "folding" type, front wheel drive power wheelchairs.
The wheelchairs are controlled using the Invacare Model MCC-MKIV RII Motor Controller and Joystick. They are powered by two Size 22NF 12 VDC batteries. Access to the batteries is gained from underneath the chairs will travel approximately 17 to 22 miles between charges, depending on use.
The wheelchairs consist of two basic sub-sections. These are the base section of the wheelchair, and the seating section of the wheelchair. Both are of welded steel construction. The base section includes the base frame, front drive wheels and axles, rear pivoting casters, motor/gearbox drive mechanism and batteries. The motor/gearbox location is adjustable, relative to the upper seating frame. This adjustment is used to compensate for weight and balance shift, which are both user dependent.
The seating, or upper section of the wheelchair, includes the seating upholstery, front foot rests, side arm rests, and joystick operating control. Seating sizes range from 14" wide to 20" wide, depending on user needs. The wheelchair motor controller is mounted to the side arm and under the backrest of the seat. The upholstery material is fabricated from either U240 Nylon, or reinforced vinyl, depending upon the user's preference. Both of these materials meet California 117 and Boston Fire Department BFD-1 specifications for fire retardancy.
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B. Substantial Equivalence
Products which are substantially equivalent to these devices are Permobil's Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997) and Invacare Corporations' Power 9000 (K900565, February 2, 1990) power wheelchairs.
Each of these products are battery powered, motor driven powered wheelchairs with the same intended function and use which is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. Similarities include large wheels with attached motor/gearbox drive mechanisms, smaller pivoting casters for turning, and joystick operated motor controllers to engage system motion and steer the wheelchair. They are all · constructed from the same basic materials, have the same basic operational principles and all use DC batteries as their source of power.
PERFORMANCE DATA
As required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three- Wheeled Vehicles", the Invacare Action Storm and Ranger II Front Wheel Drive Power Wheelchairs were tested in accordance with ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995) for powered wheelchairs and motorized scooters. In all instances, the Invacare Action Storm and Ranger II Front Wheel Drive Power Wheelchairs met the required performance criteria and functioned as intended.
15"
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
,一个
OCT 2
Mr. Edward A. Kroll Director, TQM and Regulatory Affairs Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036
Re: K982064 Action Storm Ranger II, Action Storm Power 9000 Requlatory Class: II ITI Product Code: Dated: August 25, 1998 Received: September 11, 1998
Dear Mr. Kroll:
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 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, Druq, 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.
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Page 2 - Mr. Edward A. Kroll
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Whitten, Ph.D., M
Celia M. Witten, Ph.D., M.D. Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): TBD
Device Name: Invacare Models Ranger II and Power 9000 Front Wheel Drive Power Wheelchair
Indications For Use:
To provide mobility to persons limited to a seated position.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use$\triangle$
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(Division Sia) Division of General Restorative Dev 510(k) Number