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K Number
K090108
Device Name
HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
Manufacturer
HOVEROUND CORP.
Date Cleared
2009-03-19

(63 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use is to provide mobility to persons limited to a seated position.

Device Description

Not Found

AI/ML Overview

The provided text is a U.S. FDA 510(k) clearance letter for a Hoveround Teknique FWD mk4 power wheelchair. This document is a regulatory approval for a physical medical device and does not contain information about an AI/ML device or its performance study.

Therefore, I cannot extract any details regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, or multi-reader multi-case studies as these concepts are not relevant to this type of medical device approval.

§ 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).