HOVEROUND TEKNIQUE

Wheelchair, Powered

HOVEROUND CORP.

The following data is part of a premarket notification filed by Hoveround Corp. with the FDA for Hoveround Teknique.

Pre-market Notification Details

Device IDK122741
510k NumberK122741
Device Name:HOVEROUND TEKNIQUE
ClassificationWheelchair, Powered
Applicant HOVEROUND CORP. 2151 WHITFIELD INDUSTRIAL WAY Sarasota,  FL  34243
ContactRobert Munch
CorrespondentRobert Munch
HOVEROUND CORP. 2151 WHITFIELD INDUSTRIAL WAY Sarasota,  FL  34243
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-07
Decision Date2013-05-07

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