Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K143690 · 2016-04-01

ApplicantEkso Bionics, Inc.
Decision Date2016-04-01
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Ekso™ (version 1.1) and Ekso GT™ (version 1.2) is the device name listed in this FDA 510(k) record. The listed applicant is Ekso Bionics, Inc.. It received FDA 510(k) clearance on 2016-04-01 under 510(k) number K143690. 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 2016-04-01. The listed applicant is Ekso Bionics, Inc.. The 510(k) number is K143690.

When did Ekso™ (version 1.1) and Ekso GT™ (version 1.2) receive FDA 510(k) clearance?

Ekso™ (version 1.1) and Ekso GT™ (version 1.2) received FDA 510(k) clearance on 2016-04-01, under 510(k) number K143690.

Who is the listed applicant for Ekso™ (version 1.1) and Ekso GT™ (version 1.2)?

The FDA 510(k) record lists Ekso Bionics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Ekso Bionics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220988EksoNRK200574EksoNRK161443Ekso™ (version 1.1) and Ekso GT™ (version 1.2)

Related Devices (Code: PHL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260381EveWandercraft SASK250904Atalante XWandercraft SASK241822ReWalk® 7 Personal Exoskeleton (50-20-0005)Rewalk Robotics Ltd. Dba LifewardK233695Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc.K232077Atalante XWandercraft SASK221696ReWalk P6.0Re Walk Robotics , 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.

↑