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K Number
K053574
Device Name
MEDLINE PEDIATRIC WHEELCHAIRS
Manufacturer
MEDLINE INDUSTRIES, INC.
Date Cleared
2006-01-25

(34 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

Medline Pediatric Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.

Device Description

Not Found

AI/ML Overview

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§ 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).