(31 days)
To offer to the consuming public, an electric 4-wheel scooter, that is reliable, safe and affordable.
Not Found
I am sorry, but the provided text does not contain the information requested in the prompt. The text is a letter from the FDA to American Dream International Corporation regarding the 510(k) clearance of their "Stealth," "Prowler," and "Intruder" devices, which are described as a 4-wheel electric scooter.
The letter discusses regulatory classifications and general controls, but it does not include any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot generate the table or answer the specific questions about the device's performance study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ken Casey 'President American Dream International Corporation 213 East Luzerne Avenue Larksville, Pennsylvania 18704
JUL - 3 1097
Re : K972036 Stealth K972037 Prowler K972038 Intruder Requlatory Class: II Product Code: INI Dated: June 2, 1997 Received: June 2, 1997
Dear Mr. Casey:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are 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). You may, therefore, market the devices, 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 aqainst misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General ene oood landshould ing Fract 820) and that, through periodic - - -GMP 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 devices in the Federal Register. Please note: this response to your
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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.
This letter will allow you to begin marketing your devices as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 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 your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Mark N Milbern
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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X972038 510(k) Number (if known):
Device Name: ADI 4-Whool Scooter
Indication For Use:
To offer to the consuming public, an electric 4-wheel scooter, that is reliable, safe and affordable.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109 OR
Over-The-Counter Use_
(Optional Format l-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).