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K Number
K033206
Device Name
EPW FOLDABLE POWER WHEELCHAIR, EPW-03
Manufacturer
EMG TECHNOLOGY CO., LTD.
Date Cleared
2003-12-18

(77 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 Foldable Power Wheelchair, EPW-03

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a powered wheelchair, indicating that the device is substantially equivalent to a legally marketed predicate device. It does not include details on performance metrics, study designs, sample sizes, or ground truth establishment.

§ 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).