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K Number
K240272
Device Name
Electric Scooter (M2085, S2091)
Manufacturer
Guangdong Prestige Technology Co., Ltd.
Date Cleared
2024-07-16

(167 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

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

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an "Electric Scooter (M2085, S2091)". This document does not contain information about acceptance criteria or a study proving that a device (specifically an AI/ML medical device, which is what your query implies) meets those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text. The document discusses regulatory approval for an electric scooter, not an AI software or a clinical study's findings.

§ 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).