(28 days)
The Proasia L4501 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 Proasia L4501 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 is a 510(k) summary for the Proasia L4501 scooter. This document focuses on establishing substantial equivalence to a predicate device (Bewell SC 20) and does not contain information about studies proving the device meets specific acceptance criteria in the context of AI/ML performance.
The document discusses:
- Device identification: Proasia L4501 scooter.
- Intended use: Provides transportation for disabled or elderly persons limited to a seated position, for indoor/outdoor use.
- Device description: Battery-operated, controlled by a tiller handle and thumb-operated potentiometer throttle.
- Substantial equivalence: Claimed to be substantially equivalent to the Bewell SC 20 (K043326) with minor performance differences not altering function, use, safety, or effectiveness.
Therefore, I cannot provide a response to your request, as the provided text doesn't contain the necessary information regarding acceptance criteria or the study details you've outlined, which are typically relevant for AI/ML device performance evaluations. This 510(k) pertains to a physical medical device (an electric scooter) and its regulatory clearance based on substantial equivalence, not an AI/ML algorithm.
§ 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).