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K Number
K033097
Device Name
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02
Manufacturer
TAIWAN KING STRONG CO., LTD.
Date Cleared
2003-11-12

(44 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

TAIWAN KING STRONG Powered Wheelchair, TP02

AI/ML Overview

The provided text is a U.S. FDA 510(k) clearance letter for a powered wheelchair (Taiwan King Strong Powered Wheelchair, TP02). This document focuses on regulatory approval based on "substantial equivalence" to a legally marketed predicate device.

It does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria, as typically found in a clinical performance study for AI/software as a medical device.

Therefore, I cannot extract the requested information regarding AI device performance. This document is related to a physical medical device (a powered wheelchair) and its regulatory clearance process, not an AI/software medical device.

§ 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).