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

FDA 510(k) K143690 · Ekso Bionics, Inc.

Substantially Equivalent

510(k) numberK143690

Submission

Device name
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
Applicant
Ekso Bionics, Inc.
Richmond, VA, US
Received
December 24, 2014
Decision date
April 1, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PHL – Powered Exoskeleton
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3480
Specialty
Physical Medicine

A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes.

Other 510(k)s with product code PHL

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K254198Trexo TheoPHL · Traditional Trexo Robotics, Inc.09/02/2026SE
K260381EvePHL · Traditional Wandercraft SAS08/03/2026SE
K250904Atalante XPHL · Traditional Wandercraft SAS10/24/2025SE
K241822ReWalk® 7 Personal Exoskeleton (50-20-0005)PHL · Traditional Rewalk Robotics Ltd. Dba Lifeward03/12/2025SE
K233695Medical HAL Lower Limb Type (HAL-ML)PHL · Traditional Cyberdyne, Inc.05/07/2024SE
K232077Atalante XPHL · Traditional Wandercraft SAS12/13/2023SE
K221696ReWalk P6.0PHL · Traditional Re Walk Robotics , Ltd.03/02/2023SE
K221859AtalantePHL · Traditional Wandercraft SAS12/29/2022SE
K220988EksoNRPHL · Traditional Ekso Bionics, Inc.06/09/2022SE
K213452Gems-HPHL · Traditional Samsung Electronics Co., Ltd.04/21/2022SE

More from Samsung Electronics Co., Ltd.

510(k)DeviceDecision
K220988EksoNRPHL · Traditional 06/09/2022SE
K200574EksoNRPHL · Traditional 06/19/2020SE
K161443Ekso™ (version 1.1) and Ekso GT™ (version 1.2)PHL · Traditional 07/19/2016SE

Questions and answers

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

Ekso™ (version 1.1) and Ekso GT™ (version 1.2) (K143690) received a 510(k) decision of Substantially Equivalent on April 1, 2016, 464 days after the submission was received.

What is the product code of K143690?

The FDA product code is PHL – Powered Exoskeleton, a Class II (moderate risk) device regulated under 21 CFR 890.3480.