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510(k) Data Aggregation
K Number
K014119Device Name
WU'S 3-WHEELED NEO SCOOTER, WT-M3Manufacturer
Date Cleared
2002-07-25
(220 days)
Product Code
Regulation Number
890.3800Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Predicate For
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.
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