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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered exoskeleton
510(k) Number K213452
Device Name GEMS-H
Samsung Electronics Co., Ltd.
129, Samsung-Ro, Yeongtong-Gu
Suwon-Si,  KR 16677
Applicant Contact Minhyung Lee
MDLab Inc.
Room 804, 161-17, Magokjungang-ro, Gangseo-gu
Seoul,  KR 07788
Correspondent Contact Kyoungju Kim
Regulation Number890.3480
Classification Product Code
Date Received10/26/2021
Decision Date 04/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04285060
Reviewed by Third Party No
Combination Product No