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K Number
K052586
Device Name
A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P
Manufacturer
TAIWAN AN I CO.,LTD.
Date Cleared
2005-12-09

(80 days)

Product Code
IOR
Regulation Number
890.3850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The A&I Pediatric Wheelchairs are intended to provide mobility to persons, primarily children, who may be limited to a sitting position.
The A&I Bariatric Wheelchairs are intended to provide mobility to persons, primarily larger adults, who may be limited to a sitting position.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer for wheelchairs. It confirms the substantial equivalence of the wheelchairs to previously marketed devices and outlines regulatory requirements.

This document does not contain information about the acceptance criteria or a study proving a device meets acceptance criteria. It is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the requested information.

§ 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).