(31 days)
Medline Excel Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.
Not Found
This is a 510(k) clearance letter for the Medline Excel Wheelchairs. It does not contain any information about acceptance criteria or a study proving device performance as it pertains to a medical device software (AI/ML) product. This document is a regulatory approval for a physical medical device (wheelchair) and does not involve AI performance metrics. Therefore, I cannot extract the requested information from the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Ms. Lara N. Simmons Corporate Director, Regulatory Affairs Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060-4486
K990463 Re: Medline Excel Wheelchairs Trade Name: Requlatory Class: ने Product Code: IOR August 5, 1998 Dated: February 12, 1999 Received:
Dear Ms. Simmons:
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 The general controls provisions of the Act 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 requlations 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 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 - Ms. Lara N. Simmons
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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INTENDED USE
510(k) Number (if known): (N/A)
Device Name: Medline Excel Wheelchairs
Indications for Use:
Medline Excel Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
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(Optional Format 1-2-96)
Pcsellle
(Division Sign ai Restorative Devices Division of Ge 510(k) Number
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).