(54 days)
Mobility assistive device for indoor use and outdoor use on mild terrain. Not used as a transportation vehicle on roads and freeways used by cars.
Motorized three wheeled vehicle
The provided text is a 510(k) premarket notification letter from the FDA regarding a device named "EasyTravel," which is a motorized three-wheeled vehicle. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device EasyTravel 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"
This indicates that the device was cleared based on substantial equivalence to a predicate device, not on meeting specific performance acceptance criteria from a new clinical study or AI algorithm validation.
Therefore, I cannot provide the requested information from the given text as it is not present in the document.
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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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 3 2001
Tzora Active Systems, Ltd. c/o Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112
Re: K012592
Trade/Device Name: EasyTravel Regulation Number: 890.3800 Regulation Name: Motorized three wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 20, 2001 Received: August 21, 2001
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo have 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 10 ass stated in the encreates)76, the enactment date of the Medical Device Amendments, or to conninered pror to rial) 2011-07-12, 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 Tou may, diereleve, mains 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 If your device 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 I 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. Mark Job
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will anow you to begal finding of substantial equivalence of your device to a legally premarket notification: "The PDF interessification 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 If you desire specific actrice to: 75cm vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fat 0071. I dditionally, for questions on the promotion and advertising of Compliance at (301) 594-1637. The news.com/liance at (301) 594-4639. Also, please note the your do recess, pread comable by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisoranians on your responsibilities under the Act may be obtained from the Other general monmactor on your ternational 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. Melkerson
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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510(k) Number (if known): KOI 2592
Device Name: EasyTravel
Indications For Use:
Mobility assistive device for indoor use and outdoor use on mild terrain. Not used as a transportation vehicle on roads and freeways used by cars.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98) (Division Sign-Off) (Division Sign-Oil)
Division o General, Restorative Division of Schoological Devices 510(k) Number .
SK22
§ 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).