LogoFDA 510(k) Search
K Number
K990463
Device Name
MEDLINE EXCEL WHEELCHAIRS
Manufacturer
MEDLINE
Date Cleared
1999-03-15

(31 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 Excel Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.

Device Description

Not Found

AI/ML Overview

This is a 510(k) clearance letter for the Medline Excel Wheelchairs. It does not contain any information about acceptance criteria or a study proving device performance as it pertains to a medical device software (AI/ML) product. This document is a regulatory approval for a physical medical device (wheelchair) and does not involve AI performance metrics. Therefore, I cannot extract the requested information from the provided text.

§ 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).