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K Number
K961514

Validate with FDA (Live)

Device Name
BCW ADVANTAGE WHEELCHAIR
Manufacturer
WHEELCHAIRS OF KANSAS
Date Cleared
1996-05-07

(18 days)

Product Code
IOR
Regulation Number
890.3850
Type
Traditional
Panel
Physical Medicine
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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).