(28 days)
KYMCO ForU EQ20 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.
The KYMCO ForU EQ20 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) summary and FDA approval letter for a medical device called the "KYMCO ForU EQ20 scooter."
The document focuses on:
- Device identification: Trade name, common name, classification, and intended use.
- Predicate devices: Listing two other scooters (AVANTICARE SA4022 and LERADO CHINA LIMITED ForU EQ30) as substantially equivalent.
- Substantial equivalence claim: Stating that minor performance differences do not alter the intended function, use, or safety/effectiveness.
- FDA approval: The letter confirms the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.
Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the given text. This document is a regulatory approval, not a scientific study report.
§ 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).