# K200574: EksoNR

- Pathway: 510(k) (Traditional)
- Applicant: Ekso Bionics, Inc.
- Decided: Jun 19, 2020 after 106 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: 3 generations back to DEN130034 (2014). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161443: Ekso™ (version 1.1) and Ekso GT™ (version 1.2), Ekso Bionics, Inc. (2016) Summary page 4.

## Most influential descendants
- K220988: EksoNR (2022), 0 descendants of its own

## Indications for use
The EksoNR™ is intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations: * Individuals with acquired brain injury, including traumatic brain injury and 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/K200574
Methodology: https://510kreport.com/methodology