(39 days)
K/DEN numbers not found.
Not Found
No
The description mentions sensors and controllers calculating differences and supplying auxiliary power, which is typical of traditional control systems, not necessarily AI/ML. There are no mentions of AI, ML, or related terms like neural networks or learning.
No.
The device is a manual assist wheelchair designed to provide mobility for individuals, which is not a therapeutic function. It helps with transportation, not treatment or therapy.
No
Explanation: The device is a power-assist wheelchair designed to aid mobility, not to diagnose medical conditions. Its function is to provide physical assistance for propulsion, not to analyze health data or identify diseases.
No
The device description explicitly mentions hardware components such as electric motors, a gearbox, a motor controller, and a battery.
No, 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 mobility. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The device is a wheelchair with a power assist system. It describes mechanical and electrical components for propulsion, not for analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
This device is clearly a medical device intended for mobility assistance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INDEPENDENCE™ iGlide™ Manual Assist Wheelchair is intended to provide mobility to persons limited to a seated position that are capable of operating a manual or power wheelchair.
Product codes
ITI
Device Description
The INDEPENDENCE/TM) iGLIDE(TM) Manual Assist Wheelchair is the TAILWIND Power Assist Wheelchair. With each push on the handrims, sensors and controllers calculate the difference between the effort on the handrims and the force needed to propel the chair. Electric motors supply the auxillary power needed to negotiate varying surfaces with virtually no change in effort.
The device drive consists of a gearbox with a motor controller for each side of the chair and a battery mounted underneath the chair. An on/off switch, located on the underside of the seat turns the unit on/off.
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
Non-Clinical Tests Performed: Because the new and predicate devices are the same device, no new testing is needed.
Key Metrics
Not Found
Predicate Device(s)
TAILWIND Power Assist Wheelchair
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
510(k) Summary
Image /page/0/Picture/1 description: The image shows the words "Submitters Name and Address" in bold black font. The words are stacked on top of each other. The words are centered in the image.
Independence Technology, L.L.C. 45 Technology Drive P.O.Box 4917 Warren, NJ 07059 - 4917
Contact Person
James P. O'Donnell Vice President, Regulatory Affairs Independence Technology, L.L.C. 45 Technology Drive P.O.Box 4917 Warren, NJ 07059 - 4917 908 - 412 - 2266 jodonnel(@indus.jnj.com
Date Prepared
January 22, 2003
Name of Device
INDEPENDENCE(TM) iGLIDE(TM) Manual Assist Wheelchair
Classification Name
Wheelchair, Powered
Identification of Predicate Device
TAILWIND Power Assist Wheelchair
Description of Device
The INDEPENDENCE/TM) iGLIDE(TM) Manual Assist Wheelchair is the TAILWIND Power Assist Wheelchair. With each push on the handrims, sensors and controllers calculate the difference between the effort on the handrims and the force needed to propel the chair. Electric motors supply the auxillary power needed to negotiate varying surfaces with virtually no change in effort.
The device drive consists of a gearbox with a motor controller for each side of the chair and a battery mounted underneath the chair. An on/off switch, located on the underside of the seat turns the unit on/off.
Intended Use
The INDEPENDENCE(TM) iGLIDE(TM) Manual Assist Wheelchair is intended to provide mobility to persons limited to a seated position that are capable of operating a manual or power wheelchair.
MAR 0 4 2003
1
VIND Power
20F
K030250
Comparison to Predicate Device
The NOPERNDENCE (TM) Namal Asist Wirelchair is the TALL TALL TALL PALL POS PORT POS PORT POST POST OF OF OF OF
Assis Wheeldair. The only Artes the TAILWIND Power Assist Wheelchair does have the Statement.
Non-Clinical Tests Performed
Because the new and predicate devices are the same device, no new testing is needed.
Summary
The INDEPENDENCE(TM) iGLIDE(TM) Manual Assist Wheelchair is the TAILWIND Power Assist Wheelchair. The removal of the Prescription Device Statement does not raise any questions of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an eagle or bird-like figure with three overlapping profiles, suggesting a sense of community or collaboration.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 4 2003
Mr. James P. O'Donnell Vice President, Regulatory Affairs Independence Technology, L.L.C. 45 Technology Drive P.O. Box 4917 Warren, NJ 07059-4917
Re: K030250
Trade/Device Name: iGlide™ Manual Assist Wheelchair Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 23, 2003 Received: January 24, 2003
Dear Mr. O'Donnell:
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. Iisting 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 (OS) 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. James P. O'Donnell
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 yours,
Mark M. Mellemson
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
510(k) Number (if known): KO30250
iglide™ Manual Assist Wheelchair Device Name:
Indications For Use:
The INDEPENDENCE™ iGlide™ Manual Assist Wheelchair is intended to provide mobility to persons limited to a seated position that are capable of operating a manua or power wheelchair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Jivision Sign-Off Division of General, Restorative I Neurological Devices
K030250
Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Formst 1-2-96)