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K Number
K030355
Device Name
COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202
Manufacturer
COMFORT ORTHOPEDIC CO. LTD.
Date Cleared
2003-05-20

(106 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

COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB202

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a powered wheelchair. It does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked. It generally states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the requested information from this document.

§ 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).