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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 K161443
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 Thomas Looby
Correspondent
HOGAN LOVELLS US LLP
555 THIRTEENTH STREET NW
WASHINGTON,  DC  20004
Correspondent Contact John J. Smith
Regulation Number890.3480
Classification Product Code
PHL  
Date Received05/25/2016
Decision Date 07/19/2016
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
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