• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name powered exoskeleton
510(k) Number K181294
Device Name Honda Walking Assist Device
Honda Motor Company, Ltd.
1-4-1 Chuo
Wako-shi,  JP 351-0193
Applicant Contact Kazushi Hamaya
American Honda Motor Company, Inc.
4900 Marconi Drive
Alpharetta,  GA  30005
Correspondent Contact Mark DiPietro
Regulation Number890.3480
Classification Product Code
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