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K Number
K000497
Device Name
VOYAGER/VIPER WHEELCHAIR
Manufacturer
OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
Date Cleared
2000-03-08

(22 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
Device Description
AI/ML Overview

§ 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).