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K Number
K230615
Device Name
Electric Scooter (Model: S3312)
Manufacturer
Guangdong Prestige Technology Co., Ltd.
Date Cleared
2023-05-05

(60 days)

Product Code
INI
Regulation Number
890.3800
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

I is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Device Description

Electric Scooter (Model: S3312)

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for an electric scooter and does not contain information about the acceptance criteria or a study proving device performance for a medical device that would have these types of criteria and studies associated with it.

Therefore, I cannot extract the requested information.

§ 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).