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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 K152416
Device Name Indego
Applicant
Parker Hannifin Corporation
1390 E. Highland Rd.
Macedonia,  OH  44056
Applicant Contact ACHILLEAS DOROTHEOU
Correspondent
Emergo
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact RICHARD A VINCINS
Regulation Number890.3480
Classification Product Code
PHL  
Date Received08/26/2015
Decision Date 02/26/2016
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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