FDA 510(k)

Honda Walking Assist Device

K-Number: K181294 · 2018-12-14

Decision Date2018-12-14

Product CodePHL

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Honda Walking Assist Device is a medical device manufactured by Honda Motor Company, Ltd.. It received FDA 510(k) clearance on 2018-12-14 under approval number K181294. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Honda Walking Assist Device?

Honda Walking Assist Device is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by Honda Motor Company, Ltd.. The 510(k) number is K181294.

When was Honda Walking Assist Device approved by the FDA?

Honda Walking Assist Device received FDA 510(k) clearance on 2018-12-14, under approval number K181294.

What company makes Honda Walking Assist Device?

Honda Walking Assist Device is manufactured by Honda Motor Company, Ltd..

What is the FDA product code for Honda Walking Assist Device?

The FDA product code for Honda Walking Assist Device is PHL.

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Related PubMed Literature

PMID: 36795788 Regulatory scripting: Stakeholder participation in food and drug administration medical device advisory meetings. PloS one (2023) PMID: 33579597 Berlin Heart EXCOR and ACTION post-approval surveillance study report. The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation (2021)

Related Devices (Code: PHL)

K160987ReWalk(TM)Rewalk Robotics, Inc. K161443Ekso (version 1.1) and Ekso GT (version 1.2)Ekso Bionics, Inc. K143690Ekso (version 1.1) and Ekso GT (version 1.2)Ekso Bionics, Inc. K152416IndegoParker Hannifin Corporation K171909HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc. K171334IndegoParker Hannifin Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.