(232 days)
The Powered Wheelchair is intended for use to provide mobility to The Towered "Whoolonal" is "the capability of operating a power wheelchair.
Powered Wheelchair
This document is a 510(k) clearance letter from the FDA for a Powered Wheelchair. It is a regulatory approval document and does not contain any information regarding acceptance criteria or the study data that proves the device meets those criteria, as typically found for AI/ML devices.
Therefore, I cannot extract the requested information from the provided text. The document itself is the clearance, not the detailed technical data that led to the clearance.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2004
Mr. Stephen T. Mlcoch President and CEO NATS Corporation 30 Northport Road Sound Beach, New York 11789
Re: K033142
Trade/Device Name: Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: April 15, 2004 Received: April 26, 2004
Dear Mr. Mlcoch:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 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 (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 - Mr. Stephan T. Mlcoch
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket netification. 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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 A. Mulkeron
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
K033142
Powered Wheelchair
Device Name:
Indications for Use:
The Powered Wheelchair is intended for use to provide mobility to The Towered "Whoolonal" is "the capability of operating a power wheelchair.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ × (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evalyation (ODE)
Mark A. Mulkeren
. Restorative, ど
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§ 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).