Kuschall Advance Manual Wheelchair

Wheelchair, Mechanical

INVACARE CORPORATION

The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Kuschall Advance Manual Wheelchair.

Pre-market Notification Details

Device IDK162696
510k NumberK162696
Device Name:Kuschall Advance Manual Wheelchair
ClassificationWheelchair, Mechanical
Applicant INVACARE CORPORATION ONE INVACARE WAY Elyria,  OH  44035
ContactElijah N. Wreh
CorrespondentElijah N. Wreh
INVACARE CORPORATION ONE INVACARE WAY Elyria,  OH  44035
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-27
Decision Date2016-12-28
Summary:summary

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