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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 K181294
Device Name Honda Walking Assist Device
Applicant
Honda Motor Company, Ltd.
1-4-1 Chuo
Wako-shi,  JP 351-0193
Applicant Contact Kazushi Hamaya
Correspondent
American Honda Motor Company, Inc.
4900 Marconi Drive
Alpharetta,  GA  30005
Correspondent Contact Mark DiPietro
Regulation Number890.3480
Classification Product Code
PHL  
Date Received05/16/2018
Decision Date 12/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT01994395
Reviewed by Third Party No
Combination Product No
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