EksoNR

Powered Exoskeleton

Ekso Bionics, Inc.

The following data is part of a premarket notification filed by Ekso Bionics, Inc. with the FDA for Eksonr.

Pre-market Notification Details

Device IDK200574
510k NumberK200574
Device Name:EksoNR
ClassificationPowered Exoskeleton
Applicant Ekso Bionics, Inc. 1414 Harbour Way South, Suite 1201 Richmond,  CA  94804
ContactJack Peurach
CorrespondentJack Peurach
Ekso Bionics, Inc. 1414 Harbour Way South, Suite 1201 Richmond,  CA  94804
Product CodePHL  
CFR Regulation Number890.3480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-05
Decision Date2020-06-19

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