REWALK

Powered Exoskeleton

ARGO MEDICAL TECHNOLOGIES, INC.

The following data is part of a De Novo classification by Argo Medical Technologies, Inc. with the FDA for Rewalk.

Pre-market Notification Details

DeNovo IDDEN130034
Device Name:REWALK
ClassificationPowered Exoskeleton
Applicant ARGO MEDICAL TECHNOLOGIES, INC. 33 Locke Dr. suite 240 Marlborough,  MA  01752
ContactJohn V Hamilton
Product CodePHL  
CFR Regulation Number890.3480 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK131798
Review Advisory BoardNeurology
Classification AdvisoryPhysical Medicine
TypeDirect
Date Received2013-06-17
Decision Date2014-06-26
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00861803000327 DEN130034 000
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