• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name powered exoskeleton
510(k) Number K213452
Device Name GEMS-H
Applicant
Samsung Electronics Co., Ltd.
129, Samsung-Ro, Yeongtong-Gu
Suwon-Si,  KR 16677
Applicant Contact Minhyung Lee
Correspondent
MDLab Inc.
Room 804, 161-17, Magokjungang-ro, Gangseo-gu
Seoul,  KR 07788
Correspondent Contact Kyoungju Kim
Regulation Number890.3480
Classification Product Code
PHL  
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
-
-