# K143690: Ekso™ (version 1.1) and Ekso GT™ (version 1.2)

- Pathway: 510(k) (Traditional)
- Applicant: Ekso Bionics, Inc.
- Decided: Apr 1, 2016 after 464 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: 1 generation back to DEN130034 (2014). 1 ancestor in all.
14 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130034: Rewalk, Argo Medical Technologies, Inc. (2014). Our reading of the summary gave K131798, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130034, Rewalk (Argo Medical Technologies, Inc.), granted Jun 26, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K161443: Ekso™ (version 1.1) and Ekso GT™ (version 1.2) (2016), 12 descendants of its own
- 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

## 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 with upper extremity motor function of at least 4/5 in both arms: • Individuals with hemiplegia due to stroke • Individuals with spinal cord injuries at levels T4 to L5 • Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D). 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/K143690
Methodology: https://510kreport.com/methodology