Invacare AVIVA Storm RX Power Chair

Wheelchair, Powered

Invacare Corporation

The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Invacare Aviva Storm Rx Power Chair.

Pre-market Notification Details

Device IDK202379
510k NumberK202379
Device Name:Invacare AVIVA Storm RX Power Chair
ClassificationWheelchair, Powered
Applicant Invacare Corporation One Invacare Way Elyria,  OH  44035
ContactElijah Wreh
CorrespondentElijah Wreh
Invacare Corporation One Invacare Way Elyria,  OH  44035
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-20
Decision Date2021-03-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841447114604 K202379 000
00841447114598 K202379 000
00841447114581 K202379 000

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