LogoFDA 510(k) Search
K Number
K010075
Device Name
TEKNIQUE
Manufacturer
HOVEROUND CORP.
Date Cleared
2001-02-14

(36 days)

Product Code
ITI
Regulation Number
890.3860
Type
Special
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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).