(78 days)
The intended use of the P-33 is to provide mobility to adults with the capacity to maintain a seated position on the scooter and have the capacity to operate a simple hand control.
Model P-33, Three Wheel Electric Scooter
The provided text is a 510(k) clearance letter from the FDA for a "P-33, Battery Operated, Three-Wheel Electric Scooter." This document is a regulatory approval, not a scientific study describing acceptance criteria and device performance data from a clinical trial or evaluation study.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) from the provided text. The document does not contain any of these technical details about device testing or evaluation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
MAR 2 1 2002
Transworld Mobility Distribution, LLC Mr. Juan C. Rivera President 6140 Mid Metro Drive, Suite 6 Fort Meyers, Florida 33912
Re: K020002
K020002
Trade Name: P-33, Battery Operated, Three-Wheel Electric 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 we liave reviewed your bootion of re(i) prohibed is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to indications for use stated in the choosal Device Amendments, or to device that have May 26, 1970, the chaculent dato of the Federal Food, Drug, and Cosmetic Act been reclassified in accordance will all proval application (PMA). You may, (Act) that do not require approval of a presenters controls provisions of the Act. The general therefore, market the device, subject to and generals for annual registration, listing of devices, controls provisions of the Act mender requirentibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (soc above) ans. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major research and lik be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I outsts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA studios of a basevice complies with other requirements of the Act that I DA has made a decornmissions administered by other Federal agencies. You must of ally rederal statutes and regulations and and limited to: registration and listing (21 comply with an the Act 3 requirements, normaliacturing practice requirements as set CI K I at 607), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (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) I has letter will and w yourse FDA finding of substantial equivalence of your device to a legally premated predicated 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 Compinates al (ass contact 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 O inision 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 W. Milliken
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
510K number: 《ΟΖΟΟΟ Ζ
Device Name: Model P-33, Three Wheel Electric Scooter
The intended use of the P-33 is to provide mobility to adults with the Indications For Use: Indications I or Ose. - - The micility 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)
Mark A. Wilkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number KOZOOO Z
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).