# K220988: EksoNR

- Pathway: 510(k) (Traditional)
- Applicant: Ekso Bionics, Inc.
- Decided: Jun 9, 2022 after 66 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: 4 generations back to DEN130034 (2014). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200574: EksoNR, Ekso Bionics, Inc. (2020) Summary page 4.

## Indications for use
The EksoNRm is intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations: * Individuals with multiple sclerosis (upper extremity motor function of at least 4/5 in at least one arm). * 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/K220988
Methodology: https://510kreport.com/methodology