Ekso (version 1.1) and Ekso GT (version 1.2)— 510(k) K161443

Substantially Equivalent

Ekso Bionics, Inc.

FDA 510(k) clearance K161443 for Ekso (version 1.1) and Ekso GT (version 1.2), Substantially Equivalent on 2016-07-19. Applicant: Ekso Bionics, Inc..

Clearance details

Applicant: Ekso Bionics, Inc.
Product code: Code PHL
Advisory panel: Physical Medicine
Date received: 2016-05-25
Decision date: 2016-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

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