K Number
K083847Device Name
MARVEL PEDIATRIC WHEELCHAIRManufacturer
Date Cleared
2009-01-30
(37 days)
Product Code
Regulation Number
890.3850Type
TraditionalPanel
PMReference & Predicate Devices
N/A
Predicate For
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).