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K Number
K001777

Validate with FDA (Live)

Device Name
MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
Manufacturer
INVACARE CORP.
Date Cleared
2000-07-24

(41 days)

Product Code
ITI
Regulation Number
890.3860
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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§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).