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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 K221696
Device Name ReWalk P6.0
Applicant
Re Walk Robotics , Ltd.
3 Hatnufa St.
Pob Box-161
Yokneam,  IL 2069203
Applicant Contact Miri Pariente
Correspondent
Re Walk Robotics , Ltd.
3 Hatnufa St.
Pob Box-161
Yokneam,  IL 2069203
Correspondent Contact Miri Pariente
Regulation Number890.3480
Classification Product Code
PHL  
Date Received06/10/2022
Decision Date 03/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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