(179 days)
This device is a electric powered wheelchair for indoor use, to be used by artially disabled people capable of operating a few essential hand controls. The device has similar features and uses as the predicated devices; "Jazzy" (K945936) Electric Powered Wheelchair manufactured by Pride Health Care. This device has the same intended use, safety and effectiveness as the predicated device mentioned.
This device is a electric powered wheelchair for indoor use, to be used by artially disabled people capable of operating a few essential hand controls.
The provided text is a 510(k) clearance letter from the FDA for a device named "Corsaire." It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This document only states that the device is substantially equivalent to a predicate device ("Jazzy" K945936) and can be marketed.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1999
Mr. David A. Barber Director of Quality Optiway Technology Inc. 500 Norfinch Drive Downsview, Ontario Canada M3N 1Y4
K982750 Re: Trade Name: Corsaire Regulatory Class: II Product Code: ITI December 18, 1998 Dated: Received: December 21, 1998
Dear Mr. Barber:
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, Drug, 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 Requlations, 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 (QS) 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. David A. Barber
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 requlation 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,
Mark N Milker
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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| Labels | Values |
|---|---|
| 510(k) Number (if known): | K982750 |
| Device Name: | CORSAIRE (CFTIOWAY TECHNOLOGY. INC) |
Indications For Us
This device is a electric powered wheelchair for indoor use, to be used by artially disabled people capable of operating a few essential hand controls. The device has similar features and uses as the predicated devices; "Jazzy" (K945936) Electric Powered Wheelchair manufactured by Pride Health Care. This device has the same intended use, safety and effectiveness as the predicated device mentioned.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER WAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Markn Millbur
for
(Division Sign-Off)
Division of General, Restorative,
510(k) and Neurological Devices
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Opunal Formal 1-2-96)
§ 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).