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K Number
K191897
Device Name
Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
Manufacturer
Dongguan Prestige Sporting Goods Co., Ltd.
Date Cleared
2021-02-10

(575 days)

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

It 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

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Solax Electric Scooter, a motorized three-wheeled vehicle. It does not contain any information about an AI/ML-based medical device, its acceptance criteria, or performance study details.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study for an AI/ML device based on the provided text. The document is strictly about a physical mobility device.

§ 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).