(154 days)
The Ruike 3411 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The Ruike 3411 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.
This document describes a 510(k) premarket notification for the Ruike 3411 scooter, an electrical scooter intended for transportation of disabled or elderly persons. The focus of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a detailed study with clinical outcomes.
Therefore, the provided text does not contain the information requested in points 1-9 regarding specific acceptance criteria, a study proving the device meets these criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document primarily states:
- Intended Use: The Ruike 3411 scooter is an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
- Predicate Device: The LANDLEX S400X (K 050793) manufactured by Besteam Technology Inc.
- Substantial Equivalence Claim: The Ruike 3411 scooter is substantially equivalent to the predicate device. The submission claims "minor differences in performance specifications... do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness."
In summary, this submission is not about clinical performance data demonstrating specific acceptance criteria with a study. It's about demonstrating equivalence to an already approved device based on design and intended use.
§ 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).