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K Number
K023148
Device Name
EPW POWERED WHEELCHAIR, GP-201
Manufacturer
EMG TECHNOLOGY CO., LTD.
Date Cleared
2003-01-24

(126 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

EPW Powered Wheelchair GP-201 Series

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the EPW Powered Wheelchair GP-201. It is a regulatory approval document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

Therefore, I cannot provide the requested information based on the given input. The document is solely concerned with the regulatory clearance of the device as substantially equivalent to legally marketed predicate devices.

§ 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).