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K Number
K032512
Device Name
Y.E.S POWERED WHEELCHAIR. T180
Manufacturer
YEOU EIR SHUEN MACHINERY CO., LTD.
Date Cleared
2003-11-12

(90 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
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 sitting position.

Device Description

Y.E.S. Powered Wheelchair, T180

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a powered wheelchair (Y.E.S. Powered Wheelchair, T180). This type of document declares substantial equivalence to a predicate device and allows market entry. It does not contain information about acceptance criteria, detailed device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment—these are typically found in the 510(k) submission itself, which is not provided here.

Therefore, I cannot answer your request based on the provided text. The document is administrative in nature, confirming regulatory clearance.

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).