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 IDK220988
510k NumberK220988
Device Name:EksoNR
ClassificationPowered Exoskeleton
Applicant Ekso Bionics, Inc. 1414 Harbour Way South, Suite 1201 Richmond,  CA  94804
ContactScott Davis
CorrespondentMichael Glover
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 Received2022-04-04
Decision Date2022-06-09

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