(60 days)
The intended use of Travel Ease Electric Scooter, Pioneer 2 is to provide mobility to adult persons limited to a sitting position and capable of operating a few simple controls.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Travel Ease Electric Scooter, Pioneer 2." It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. This means that the device is considered as safe and effective as a previously cleared device.
Therefore, I cannot extract the requested information from this document. The document primarily focuses on the regulatory clearance and substantial equivalence determination, not on detailed performance studies or acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wing-like shapes, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
AUG - 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Winston Anderson Vice President MERITS Health Products, Inc. P.O. Box 150356 Cape Coral, Florida 33915
Re: K011707
Trade/Device Name: Travel Ease Electric Scooter, Pioneer 2 Regulation Number: 890.3800 Regulatory Class: II Product Code: INI Dated: July 25, 2001 Received: July 25, 2001
Dear Mr. Anderson:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave 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 stired in the energently to regionent date of the Medical Device Amendments, or to devices that price to rial) 20, 20, 2011, 11:45 provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costions of the Act. The general controls provisions of the Act include requirements for annual provisions of 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Winston Anderson
This letter will allow you to begin marketing your device as described in your 510(k) premarket I ntification. 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 and 11 you active 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for millionally, for questions on the promotion and advertising of your device, (2017) 594-1639. I rush of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Mmmhhmma
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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Page_of_of____________________________________________________________________________________________________________________________________________________________________
Comments of the comments of 510(k) Number (if known):
Travel Ease Electric Scooter, Pioneer 2 Device Name:_
Indications For Use:
The intended use of Travel Ease Electric Scooter, Pioneer 2 is to provide mobility to adult persons limited to a sitting position and capable of operating a few simple controls.
leRda
Winston Anderson Vice President Merits Health Products, Inc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MAMuhleUDO for ann
(Division Sign-Coff) (Division of General, Restorative and Neurological Devices
510(k) Number K071707
OR Over-The-Counter UseX
(Optional Format 1-2-96)
Prescription Use (Per 21 CFR 801.109)
§ 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).