EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR

Wheelchair, Powered

OTTO BOCK ORTHOPEDIC INDUSTRY, INC.

The following data is part of a premarket notification filed by Otto Bock Orthopedic Industry, Inc. with the FDA for Evantgarde/endeavor Powered Wheelchair.

Pre-market Notification Details

Device IDK000739
510k NumberK000739
Device Name:EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR
ClassificationWheelchair, Powered
Applicant OTTO BOCK ORTHOPEDIC INDUSTRY, INC. 3000 XENIUM LANE, SUITE N Plymouth,  MN  55441
ContactWilliam Jackson
CorrespondentWilliam Jackson
OTTO BOCK ORTHOPEDIC INDUSTRY, INC. 3000 XENIUM LANE, SUITE N Plymouth,  MN  55441
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-07
Decision Date2000-10-24

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