# K201473: ExoAtlet-II

- Pathway: 510(k) (Traditional)
- Applicant: Exoatlet Asia Co., Ltd.
- Decided: Jul 16, 2021 after 408 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
The ExoAtlet-II is 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 at least 4/5 in both arms: * 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 device is not intended for sports or stair climbing.

Source page: https://510kreport.com/device/K201473
Methodology: https://510kreport.com/methodology