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K Number
K014119
Device Name
WU'S 3-WHEELED NEO SCOOTER, WT-M3
Manufacturer
WU'S TECH CO., LTD.
Date Cleared
2002-07-25

(220 days)

Product Code
INI
Regulation Number
890.3800
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
K033032
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification approval letter for a medical device called "Wu's 3-Wheeled Neo Scooter, WT-M3". It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on the FDA's regulatory decision regarding the substantial equivalence of the device to a predicate 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).