(58 days)
The intended use of Travel Ease Electric Scooter, Pioneer 4 is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
Travel Ease Electric Scooter, Pioneer 4
I am sorry, but the provided text from the FDA 510(k) summary for the "Travel Ease Electric Scooter, Pioneer 4" does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details regarding a medical device's performance evaluation as requested in your prompt.
The document is a clearance letter from the FDA, confirming that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It discusses regulatory matters such as the device's classification, general controls, and compliance with regulations, but it does not include performance data or studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.
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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: K011753
Trade/Device Name: Travel Ease Electric Scooter, Pioneer 4 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 devident of a we nave reviewed your Section 9 rotty neversantially equivalent (for the indications for use above and we nave determined the actreced predicate devices marketed in interstate commerce Stated in the enclosure) to logally manove of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). Tou may, dicrerers, lannovisions of the Act include requirements for annual provisions of the Act. "The general controls process 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 (Fremarket Approval), it may of sale of Federal Regulations, Title 21, Parts 800 to 895. arreculty equivalent determination assumes compliance with the Current Good A substantially equirements, 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 mispections, the rood and Drag result in regulatory action. In addition, FDA may publish comply with the GMT Togalazer and our 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 notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. The I Driving of castion 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 desire specific arriver diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in viao alaguestions on the promotion and advertising of your device, (301) 594-4639. 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 miormation on your responsibility free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Amuleeson on
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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K011753
Page 1 of 1
ROOM STATE 510(k) Number (if known);
Travel Ease Electric Scooter, Pioneer 4 Device Name:
Indications For Use:
The intended use of Travel Ease Electric Scooter, Pioneer 4 is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
elbert C. Cole
William Anderson
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)
osmithelity so career (Division Sign-Off) Division of General, Restorative
and Neurological Devices
Kollars 510(k) Number -Over-The-Counter Use V Prescription Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 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).