(265 days)
The power wheelchair is used as a mobility device for individuals who have limited The power which is assult is assult in the wheelchair is designed especially for larger individuals and can be used for outside mobility or in clinical applications.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a power wheelchair, the Overlander PEV 2000. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance characteristics.
The letter focuses on the substantial equivalence determination for regulatory purposes, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and good manufacturing practices.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 29 1999
Mr. Willard L. Frickey President and CEO Wheelchairs of Kansas P.O. Box 320 204 West 2nd Street Ellis. Kansas 67637
K983497 Re: Trade Name: Overlander PEV 2000 Regulatory Class: II Product Code: ITI Dated: March 1. 1999 Received: May 3, 1999
Dear Mr. Frickey:
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 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 (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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. Willard L. Frickey
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. 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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Image /page/2/Picture/0 description: The image is a logo for "Wheelchairs of Kansas". The logo is in black and white and features a stylized wheelchair in the shape of the state of Kansas. The phone number 1-800-537-6454 and fax number 800-337-2447 are listed below the company name.
P.O. Box 320 · 204 W. 2nd St. · Ellis. KS 67637
Raye's INC. 204 West 2nd Street Ellis, KS 67637
510 (k) Number: K983497
Service Name: Overlander PEV 2000
Indication – or Use:
The power wheelchair is used as a mobility device for individuals who have limited The power which is assult is assult in the wheelchair is designed especially for larger individuals and can be used for outside mobility or in clinical applications.
Wilbur Hunch
Willard Lee Frickey, President Wheelchairs of Kansas
11-8-98
Date
Pcotleffo
(Director, Offi
D. eneral Restorative Devices K9834
510(K) Number
Over-the-Counter Use X
Image /page/2/Picture/14 description: The image shows a close-up of three rectangular objects. The objects are arranged side-by-side, and they appear to be made of a solid material. The objects are dark in color, and they have a rough texture. The image is slightly blurry, and the lighting is uneven.
§ 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).