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K Number
K042652
Device Name
TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR
Manufacturer
TAIWAN KING STRONG CO., LTD.
Date Cleared
2004-11-04

(37 days)

Product Code
IOR
Regulation Number
890.3850
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 person restricted to a sitting position.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a mechanical wheelchair, indicating that the device is substantially equivalent to a legally marketed predicate device. It does not contain details about specific performance metrics, studies, or ground truth establishment.

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).