(78 days)
The intended use of the PF-3 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.
Model PF-3, Four Wheel Electric Scooter
This document is a 510(k) premarket notification letter from the FDA regarding a motorized four-wheel power scooter (PF-3). It confirms substantial equivalence to a legally marketed predicate device.
The provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. It is a regulatory approval letter, not a scientific study report.
Therefore, I cannot fulfill your request for the specific information about acceptance criteria and the study proving the device meets them based on the given input.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
MAR 2 1 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Transworld Mobility Distribution, LLC Mr. Juan C. Rivera President 6140 Mid Metro Drive, Suite 6 Fort Meyers, Florida 33912
Re: K020001
Trade Name: PF-3, Battery Operated, Four Wheel Power Scooter Regulation Number: 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: II Product Code: INI Dated: December 30, 2001 Received: January 2, 2002
Dear Mr. Rivera:
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 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. Juan Rivera
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter witification. The FDA finding of substantial equivalence of your device to a legally premated 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 21 CFR Part 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 compliance we ( every of the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Ourision 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,
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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Indications for Use Statement
KU20001 510K number:
Device Name: Model PF-3, Four Wheel Electric Scooter
The intended use of the PF-3 is to provide mobility to adults with the Indications For Use: ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Mark N. Mellkinn
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number KoZOON
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use_
§ 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).