(23 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard power wheelchair and does not mention any AI/ML capabilities or related performance metrics.
No.
This device is a power wheelchair, which provides mobility assistance rather than directly treating a medical condition or restoring normal bodily function in a therapeutic sense.
No
The device is a power wheelchair, which is a mobility aid, not a diagnostic tool used to identify or analyze medical conditions.
No
The device description clearly outlines a physical, battery-powered electric motor-driven wheelchair with a frame, seat, armrests, and footrests, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to individuals with limited sitting ability who can operate a power wheelchair. This is a mechanical function for physical assistance.
- Device Description: The description details a mechanical device with a frame, wheels, motors, and seating components. It focuses on providing mobility.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The Frontier Power Wheelchair does not perform any such tests. It is a mobility aid.
N/A
Intended Use / Indications for Use
The intended use of the Frontier Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
Product codes
ITI
Device Description
The Frontier Power Wheelchair is a battery powered, electric motor driven device with the intended function of providing mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. It is a mid wheel drive format wheelchair as it's basic configuration with direct drive motors and four swivel castors. The wheelchair frame is of a non-folding type with a mid mounted drive wheels on individual, front pivoting extension arms ending in front mounted swivel castors. The rear of the main frame ends with a lateral pivoting beam arm with swivel castors mounted on each side. This frame design allows for all 6 wheels to contact the ground over uneven terrain.
The frame consists of a combination of 2" diameter round steel tube. 1 ¼" diameter round steel tube and 1 ¼" square tube. The wheelchair consists of the following basic components: frame with articulated drive wheels and casters, seat, armrests, and footrests.
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
As required by FDA's July 26, 1995 draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Application for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles", the Frontier Power Wheelchair was tested in accordance with ISO/CD 7176-21 and ANSI/RESNA Vol.2 Section 21 Amendments for powered wheelchairs and motorized scooters. In all instances, the Frontier Power Wheelchair met the required performance criteria and functioned as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 0 4 2003
510(k) Summary Innovation In Motion 510(k) Premarket Notification Frontier Power Wheelchair
Applicant's Name, Address, Telephone, and Fax Numbers
Innovation In Motion 900 Growth Parkway PO Box 507 Angola, IN 46703 Phone 260.668.5677 Fax: 260.668.8967
Preparer's Name, Address, Telephone, Fax Number, Contact Name, and Date Prepared
Innovation In Motion 900 Growth Parkway PO Box 507 Angola, IN 46703 Phone 260.668.5677 Fax: 260.668.8967
Contact Person: Rick Michael North America Sales Manager
Date Prepared: February 2003
Manufacturer's Name, Address, Telephone, and Fax Numbers
Magic International Pty. Ltd. 2 / 16 Viewtech Place Rowville, Victoria 3178 Australia Phone: 011.613.9755.8100 Fax: 011.613.9755.8111
Name of Device and Name/Address of Sponsor:
Frontier Power Wheelchair
Innovation In Motion 900 Growth Parkway PO Box 507 Angola, IN 46703 Phone 260.668.5677 Fax: 260.668.8967
1
Common or Usual Name
Power Wheelchair
Classification Name Wheelchair, Powered
Predicate Devices
The product that is substantially equivalent to the Frontier Power Wheelchair is Invacare's Xterra GT Power Wheelchair (K012909, October 24, 2001).
Intended Use
The intended use of the Frontier Power Wheelchair 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
Device Description:
The Frontier Power Wheelchair is a battery powered, electric motor driven device with the intended function of providing mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. It is a mid wheel drive format wheelchair as it's basic configuration with direct drive motors and four swivel castors. The wheelchair frame is of a non-folding type with a mid mounted drive wheels on individual, front pivoting extension arms ending in front mounted swivel castors. The rear of the main frame ends with a lateral pivoting beam arm with swivel castors mounted on each side. This frame design allows for all 6 wheels to contact the ground over uneven terrain.
The frame consists of a combination of 2" diameter round steel tube. 1 ¼" diameter round steel tube and 1 ¼" square tube. The wheelchair consists of the following basic components: frame with articulated drive wheels and casters, seat, armrests, and footrests.
Substantial Equivalence:
Both of these products are battery powered wheelchairs with the same intended function and use-the provision of mobility to persons limited to a sitting position that have the capability of operating a powered wheelchair. Similarities include large mid-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.
The Frontier Power Wheelchair is substantially equivalent to Invacare's Xterra GT Power Wheelchair (ZX2) (K012909, October 24, 2001).
2
Performance Data:
As required by FDA's July 26, 1995 draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Application for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles", the Frontier Power Wheelchair was tested in accordance with ISO/CD 7176-21 and ANSI/RESNA Vol.2 Section 21 Amendments for powered wheelchairs and motorized scooters. In all instances, the Frontier Power Wheelchair met the required performance criteria and functioned as intended.
. . . .
3
Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name encircling an abstract image of an eagle. The eagle is depicted with stylized lines, suggesting movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 4 2003
Mr. Rick Michael North America Sales Manager Vestil Manufacturing Corporation 900 Growth Parkway Angola, IN 46703
Re: K030783
Trade/Device Name: Frontier Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: March 25, 2003 Received: March 26, 2003
Dear Mr. Michael:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) 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 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 (PMA), 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 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. Rick Michael
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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 Manufacturers, 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/cdrh/dsma/dsmamain.html
Sincerely vours
Mark N. Mellem
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
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Page_1__of__1_
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:Frontier Power Wheelchair__
Indications For Use:
The indended use of the Frontier Power wheelchair is to provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
(Division Sign-Off)
Division of General. Restorative
and Neurological Devices
| 510(k) Number | K030783 |
|---|---|
| --------------- | --------- |
| OR Over-The-Counter Use ✓ | |
|---|---|
| -- | ---------------------------------------------------------------------------- |
ption Use
CFR 801.109)(Optional Format 1-2-96)
Prescrip (Per 21 C.
B 3