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K Number
K100350
Device Name
HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT
Manufacturer
HOVEROUND CORP.
Date Cleared
2010-03-22

(38 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

This document is a 510(k) clearance letter from the FDA for the Hoveround Teknique GT Powered Wheelchair. It does not contain the acceptance criteria, study details, or performance data of the device.

Therefore, I cannot answer your request based on the provided text. The document confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not include the technical performance specifications or study results you are asking for.

§ 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).