(13 days)
Not Found
No
The description focuses on mechanical and electrical components for power assist, with no mention of AI/ML terms or functionalities like learning or adaptive control based on user input or environment.
No
The device is a power-assist wheelchair designed to enhance mobility, not to treat or cure a medical condition.
No
The device description indicates it is a power-assist wheelchair providing enhanced mobility, not a device for diagnosing medical conditions. The performance studies mentioned refer to ISO standards for wheelchairs, not diagnostic accuracy.
No
The device description clearly states it is a wheelchair with physical components like motors, drive wheels, and batteries, indicating it is a hardware device with power assist functionality, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "empower physically challenged persons by providing a means of enhanced mobility." This is a functional, mobility-enhancing purpose, not a diagnostic one.
- Device Description: The description details a power assist wheelchair with motors, drive wheels, and batteries. This is a mechanical and electrical device for physical movement, not for analyzing biological samples.
- 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 substances in the body
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is clearly a medical device, specifically a power assist wheelchair, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The TAILWIND power assist wheelchair empowers physically challenged persons by providing a means of enhanced mobility.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The TAILWIND power assist wheelchair is a light duty, conventional, rear wheel drive, rigid wheelchair. The TAILWIND wheelchair incorporates power assist components with a typical manual wheelchair. As a motorized wheelchair, it contains motors, drive wheels, and batteries.
The wheelchair is propelled using a mix of human power to manually turn the chair wheels; this action activates the power assist electric motors to provide a short burst of supplementary power.
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)
All applicable tests were voluntarily conducted in accordance with ISO 7176, including Parts 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, 16, and 21. Where applicable a 100 kg dummy (plus 13.4 kg) as specified in ISO 7176 - 11 was used.
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.
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
AUG 2 7 2002
Image /page/0/Picture/1 description: The image shows the logo for DeltaGlide. The logo consists of the letters 'DG' in a stylized font, with the word 'DELTAGLIDE' written below it in a sans-serif font. Below the word 'DELTAGLIDE' is the phrase 'power for people' in a smaller, sans-serif font.
Image /page/0/Picture/2 description: The image shows the text "KO22704" and "P. 1/2" on the top line. Below that, the text "CONFIDENTIAL DOCUMENT" is written in bold and all caps. The text appears to be handwritten, and the image is likely a scan of a document.
510(k) Summary
Submitter's Name and Address
DeltaGlide, Inc. 3 Industrial Circle Hamden, CT 06517 Phone: (203) 230-0301 Fax: (203) 230-0303
Contact Person
Jere Perchy Vice President of Operations DeltaGlide, Inc. 3 Industrial Circle Hamden, CT 06517 (203) 230-0301 extension 102 iperchy@deltaglide.com
Date Prepared June 7, 2002
Name of Device TAILWIND
Classification Name Wheelchair, Powered
Identification of Predicate Device Sunrise Medical Model Quickie 2 Power Assist Wheelchair (K001491)
Description of the Device
The TAILWIND power assist wheelchair is a light duty, conventional, rear wheel drive, rigid wheelchair. The TAILWIND wheelchair incorporates power assist components with a typical manual wheelchair. As a motorized wheelchair, it contains motors, drive wheels, and batteries.
The wheelchair is propelled using a mix of human power to manually turn the chair wheels; this action activates the power assist electric motors to provide a short burst of supplementary power.
3 Industrial Circle
Hamden,
ecticut
ı 7
203.230.0301 telephone
203.230.0303 telefax
1
Confidential Document
02/2
Intended Use
The TAILWIND power assist wheelchair empowers physically challenged persons by providing a means of enhanced mobility.
Comparison to Predicate Device
The device (Tailwind Wheelchair) has similar technological characteristics as the predicated device (Sunrise Medical Model Quickie 2 Power Assist Wheelchair). The device and the predicate are typical manual wheelchair frames; they use aluminum and steel in their frames and components, and standard material and covers for the back upholstery and cushions. Microprocessors are used. Motors employ direct electrical current with rechargeable batteries for an energy source. The operating speeds and maneuverability are equivalent, and the wheelchairs are recommended for indoor and light outdoor use. Standard accessories and components are common.
Both devices use a mix of human and electrical power to propel the wheelchair. Both devices are controlled (steering, braking and accelerating) by means of the handrims. Both devices can be used with the power units turned off. Both devices use conventional wheel locks.
Non-Clinical Tests Performed
All applicable tests were voluntarily conducted in accordance with ISO 7176, including Parts 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, 16, and 21. Where applicable a 100 kg dummy (plus 13.4 kg) as specified in ISO 7176 - 11 was used.
Summarv
The TAILWIND power assist wheelchair is substantially equivalent to the Sunrise Medical Model Quickie 2 Power Assist Wheelchair in design, function, and features. As shown by the non-clinical testing, any differences between the TAILWIND power assist wheelchair and the predicate device do not raise any questions of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on top of each other, with 'Public' and 'Health' on the first line and 'Service' on the second line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2002
DeltaGlide, Inc. c/o Mr. Heinz Joerg Steneberg Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Road Newton, CT 06470
Re: K022704
Trade/Device Name: Tailwind Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: July 16, 2002 Received: August 14, 2002
Dear Mr. Steneberg:
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.
3
Page 2 - Mr. Heinz Joerg Steneberg
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Sincerely, yours,
Mark A. Mikkelsen
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
Attachment 1: Indications for Use Form
Page 1 of
510(k) Number (if known): KO22704
Device Name: TAILWIND
Indications For Use:
The TAILWIND power assist wheelchair empowers physically challenged persons by providing a means of enhanced mobility.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millkerson
sion of General, Restorative and Neurological Devices
510(k) Number _K022704
(Optional Format 3-10-98)