(24 days)
The Gazelle Wheelchair is a lightweight manual wheelchair designed for individuals who need assistance in transportation. It provides mobility based upon an individual user's needs and capabilities.
Not Found
This document is a 510(k) clearance letter from the FDA for a mechanical wheelchair, specifically the "Gazelle Wheelchair." It primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, the input document does not contain any information regarding acceptance criteria or a study proving device performance in the context of medical efficacy or diagnostic accuracy. This type of information would typically be found in a clinical study report or a pre-submission document detailing performance metrics.
As a result, I cannot provide the requested information. The document is strictly a regulatory clearance notice and lacks the details about performance studies.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2002
Alum Creek Wheelchair Co., Inc. Richard A. Roy, M.D., F.A.C.S. 393 East Town Street, Suite 228 Columbus, Ohio 43215
Re: K020536
Trade Name: Gazelle Wheelchair Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: I Product Code: IOR Dated: February 18, 2002 Received: February 19, 2002
Dear Dr. Roy:
We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general chorolor, mainons 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Dr. Richard Roy
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to begal finding of substantial equivalence of your device to a legally premaired 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 II you desire specific ad 1.00 for you in vitro diagnostic devices), please contact the Office of additionally 21 CHT Fur 8091. Additionally, for questions on the promotion and advertising of Compinance at (301) 594-4639 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation on therea, "Thise and in responsibilities under the Act may be obtained from the Oinor goneral international and Consumer 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,
Mark N. Millhiser
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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K020536 510(k) Number (if known): _
GAZELLE WHEELCHAIR Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Gazelle Wheelchair is a lightweight manual wheelchair designed for individuals who need assistance in transportation. dealthed for morovides mobility based upon an individual userts needs and capabilities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-9G)
Mark A Wilkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number __K
§ 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).