Powered Exoskeleton

Samsung Electronics Co., Ltd.

The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gems-h.

Pre-market Notification Details

Device IDK213452
510k NumberK213452
Device Name:GEMS-H
ClassificationPowered Exoskeleton
Applicant Samsung Electronics Co., Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si,  KR 16677
ContactMinhyung Lee
CorrespondentKyoungju Kim
MDLab Inc. Room 804, 161-17, Magokjungang-ro, Gangseo-gu Seoul,  KR 07788
Product CodePHL  
CFR Regulation Number890.3480 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-26
Decision Date2022-04-21

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