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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 K190337
Device Name ReWalk Restore
Applicant
Re Walk Robotics , Ltd.
3 Hetnufa St., Pob Box-161
Yokneam,  IL 2069203
Applicant Contact Ofir Koren
Correspondent
Re Walk Robotics , Ltd.
3 Hetnufa St., Pob Box-161
Yokneam,  IL 2069203
Correspondent Contact Ofir Koren
Regulation Number890.3480
Classification Product Code
PHL  
Date Received02/14/2019
Decision Date 06/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03499210
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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