(196 days)
The Electric Mobility Cavalier Scooter is intended to serve the needs of individuals who have limited mobility.
Not Found
This document is a 510(k) clearance letter from the FDA to Electric Mobility Corporation for their "Cavalier Scooters". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulations the company must follow.
Therefore, I cannot provide the requested information based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 1993
Mr. Mark Hoskin Product Manager Electric Mobility Corporation 1 Mobility Plaza Sewell, New Jersey 08080
Re: K991281 Electric Mobility "Cavalier Scooters" Trade Name: Requlatory Class: II Product Code: INI Dated: September 13, 1999 Received: September 14, 1999
Dear Mr. Hoskin:
We have reviewed your Section 510(k) notification of intent to we have reviewed your renced above and we have determined the marker the substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate ass beated for to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been nedical bevroe imenamentoce 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 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 on regulations .
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Page 2 - Mr. Mark Hoskin
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 or your device to a legally
device and this - permits manults 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) 594-46597 prease Contact the Unice of Compliance at (301)
Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please consist the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to sharket 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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K991281 510(k) Number (if known):
Device Name: Electric Mobility "Cavalier Scooters"
Indications For Use:
The Electric Mobility Cavalier Scooter is intended to serve the needs of individuals who have limited mobility.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P. Osefo
(Division Sign-Off) Division of General Restorative De 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).