(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.
§ 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).