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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 K173530
Device Name Indego(R)
Parker-Hannifin Corporation
1390 E. Highland Road
Macedonia,  OH  44056
Applicant Contact Achilleas Dorotheou
Emergo Global Consulting, LLC
2500 Bee Cave Road, Bldg 1, Suite 300
Austin,  TX  78746
Correspondent Contact Audrey Swearingen
Regulation Number890.3480
Classification Product Code
Date Received11/15/2017
Decision Date 01/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03054064
Reviewed by Third Party No
Combination Product No