# K161443: Ekso™ (version 1.1) and Ekso GT™ (version 1.2)

- Pathway: 510(k) (Traditional)
- Applicant: Ekso Bionics, Inc.
- Decided: Jul 19, 2016 after 55 days
- Product code: PHL (Powered Exoskeleton)
- Device class: 2
- Regulation: 21 CFR 890.3480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN130034 (2014). 2 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143690: Ekso™ (version 1.1) and Ekso GT™ (version 1.2), Ekso Bionics, Inc. (2016) Summary page 4.

## Most influential descendants
- K171334: Indego (2017), 6 descendants of its own
- K173530: Indego (R) (2018), 5 descendants of its own
- K221859: Atalante (2022), 3 descendants of its own
- K232077: Atalante X (2023), 2 descendants of its own
- K181294: Honda Walking Assist Device (2018), 2 descendants of its own

## Indications for use
The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population: • Individuals with hemiplegia due to stroke (upper extremity motor function of at least 4/5 in at least one arm) • Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms) • Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms). The therapist must complete a training program prior to use of the device. The devices are not intended for sports or stair climbing.

Source page: https://510kreport.com/device/K161443
Methodology: https://510kreport.com/methodology