Powered Exoskeleton

ExoAtlet Asia Co. Ltd.

The following data is part of a premarket notification filed by Exoatlet Asia Co. Ltd. with the FDA for Exoatlet-ii.

Pre-market Notification Details

Device IDK201473
510k NumberK201473
Device Name:ExoAtlet-II
ClassificationPowered Exoskeleton
Applicant ExoAtlet Asia Co. Ltd. 4582 S. Ulster Streer, Suite 205 Denver,  CO  80237
ContactBret Bostock
CorrespondentAllison C Komiyama
AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego,  CA  92110
Product CodePHL  
CFR Regulation Number890.3480 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-03
Decision Date2021-07-16

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