(64 days)
The intended use of the MP3C is to provide mobility to adults, who have the capability to operate a few simple controls and the ability to control a power wheelchair.
MP3C Power Base Chair, Model MP3C
This document is a 510(k) clearance letter from the FDA for a power-operated chair, the "MP3C Power Base Chair, Model MP3C". It states that the device is substantially equivalent to legally marketed predicate devices.
This document does NOT contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth, or an MRMC comparative effectiveness study.
The letter is a regulatory approval, not a technical report or study summary. Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
AUG - 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Winston Anderson Vice President MERITS Health Products, Inc. P.O. Box 150356 Cape Coral, Florida 33915
Re: K011687
Trade/Device Name: MP3C Power Base Chair, Model MP3C Regulation Number: 890.3860 Regulatory Class: II Product Code: ITI Dated: July 25, 2001 Received: July 25, 2001
Dear Mr. Anderson:
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 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). 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 requirements, 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. Winston Anderson
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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
MMMMMMMMMM for can
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
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Page 1 of 1
510(k) Number (if known): K011687
MP3C Device Name:_
Indications For Use:
The intended use of the MP3C is to provide mobility to adults, 1 lie michded use of the his bave the capability to operate a few ninked to a situing posses.
simple controls and the ability to control a power wheelchair.
Winston Anderson
Vice President Merits Health Products
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DSmt clullers for clu
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011687
OR Over-The-Counter Use √
Prescription Use (Per 21 CFR 801.109)
(Optional Format 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).