(31 days)
The intended use of this product is to provide freedom and mobility to persons who have difficulty walking. Hour electric ----scooter will provide freedom of movement at an affordable price.
Not Found
I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA, which confirms that certain devices (Stealth K972036, Prowler K972037, Intruder K972038) are substantially equivalent to previously marketed devices.
While it mentions the "intended use" for the Stealth scooter (K972036), it does not detail:
- Specific acceptance criteria (e.g., performance metrics, thresholds).
- Any details about a study conducted to demonstrate performance against such criteria.
- Information related to sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request based on the provided input.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH - HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JUL - 3 :097
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
K972036 Re : 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 You may, of the Federal Food, Drug, and Cosmetic Act (Act). 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, qood manufacturing practice, labeling, and prohibitions against 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 requlations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Reqister. Please note: this response to your
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Page 2 - Mr. Ken Casey
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 regulation (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 ene regulation Cherorou, 112FR 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 Milbers
Colin M. Hitton Ph.D., M.D.
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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K 972036 - STEALTH, 24V ELECTRIC
SCOOTER
INTENDED USE
The intended use of this product is to provide freedom and mobility to persons who have difficulty walking. Hour electric ----scooter will provide freedom of movement at an affordable price.
Mark N. Milbauer
(Division Sign-Off)
Over-the-Counter Use X
§ 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).