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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 K143690
Device Name Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
Applicant
EKSO BIONICS, INC.
1414 HARBOUR WAY SOUTH, SUITE 1201
RICHMOND,  VA  94804
Applicant Contact JOHN TUGWELL
Correspondent
EKSO BIONICS, INC.
1414 HARBOUR WAY SOUTH, SUITE 1201
RICHMOND,  CA  94804
Correspondent Contact Thomas Looby
Regulation Number890.3480
Classification Product Code
PHL  
Date Received12/24/2014
Decision Date 04/01/2016
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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