FDA 510(k)

Ekso (version 1.1) and Ekso GT (version 1.2)

K-Number: K161443 · 2016-07-19

Decision Date2016-07-19

Product CodePHL

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Ekso (version 1.1) and Ekso GT (version 1.2) is a medical device manufactured by Ekso Bionics, Inc.. It received FDA 510(k) clearance on 2016-07-19 under approval number K161443. 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 Ekso (version 1.1) and Ekso GT (version 1.2)?

Ekso (version 1.1) and Ekso GT (version 1.2) is a medical device that received FDA 510(k) clearance on 2016-07-19. It is manufactured by Ekso Bionics, Inc.. The 510(k) number is K161443.

When was Ekso (version 1.1) and Ekso GT (version 1.2) approved by the FDA?

Ekso (version 1.1) and Ekso GT (version 1.2) received FDA 510(k) clearance on 2016-07-19, under approval number K161443.

What company makes Ekso (version 1.1) and Ekso GT (version 1.2)?

Ekso (version 1.1) and Ekso GT (version 1.2) is manufactured by Ekso Bionics, Inc..

What is the FDA product code for Ekso (version 1.1) and Ekso GT (version 1.2)?

The FDA product code for Ekso (version 1.1) and Ekso GT (version 1.2) is PHL.

Other Devices by Ekso Bionics, Inc.

K143690Ekso (version 1.1) and Ekso GT (version 1.2) K200574EksoNR K220988EksoNR

Related Devices (Code: PHL)

K160987ReWalk(TM)Rewalk Robotics, 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 K181294Honda Walking Assist DeviceHonda Motor Company, Ltd.

Official Source

View on FDA Database →

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