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

Powered Exoskeleton

EKSO BIONICS, INC.

The following data is part of a premarket notification filed by Ekso Bionics, Inc. with the FDA for Ekso™ (version 1.1) And Ekso Gt™ (version 1.2).

Pre-market Notification Details

• Device ID: K161443
• 510k Number: K161443
• Device Name: Ekso™ (version 1.1) And Ekso GT™ (version 1.2)
• Classification: Powered Exoskeleton
• Applicant: EKSO BIONICS, INC. 1414 HARBOUR WAY SOUTH, SUITE 1201 Richmond, VA 94804
• Contact: Thomas Looby
• Correspondent: John J. Smith; HOGAN LOVELLS US LLP 555 THIRTEENTH STREET NW Washington, DC 20004
• Product Code: PHL
• CFR Regulation Number: 890.3480 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-05-25
• Decision Date: 2016-07-19
• Summary: summary