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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 K171334
Device Name Indego
Applicant
Parker Hannifin Corporation
1390 E. Highland Rd.
Macedonia,  OH  44056
Applicant Contact Achilleas Dorotheou
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Audrey Swearingen
Regulation Number890.3480
Classification Product Code
PHL  
Date Received05/08/2017
Decision Date 09/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02202538
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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