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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 K200574
Device Name EksoNR
Applicant
Ekso Bionics, Inc.
1414 Harbour Way S., Suite 1201
Richmond,  CA  94804
Applicant Contact Jack Peurach
Correspondent
Ekso Bionics, Inc.
1414 Harbour Way S., Suite 1201
Richmond,  CA  94804
Correspondent Contact Jack Peurach
Regulation Number890.3480
Classification Product Code
PHL  
Date Received03/05/2020
Decision Date 06/19/2020
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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