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: K143690
• 510k Number: K143690
• 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: John Tugwell
• Correspondent: Thomas Looby; EKSO BIONICS, INC. 1414 HARBOUR WAY SOUTH, SUITE 1201 Richmond, CA 94804
• Product Code: PHL
• CFR Regulation Number: 890.3480 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-24
• Decision Date: 2016-04-01
• Summary: summary