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

Name: FDA 510(k) clearance K161443
Creator: U.S. Food and Drug Administration
Published: 2016-07-19

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.. Device class: 2.

Clearance details

Applicant: Ekso Bionics, Inc.
Product code: Code PHL
Device class: Class 2
Regulation: 21 CFR 890.3480
Advisory panel: Physical Medicine
Date received: 2016-05-25
Decision date: 2016-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.