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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 Dr.
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
Predetermined Change
Control Plan Authorized		 No
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