# K250904: Atalante X

- Pathway: 510(k) (Traditional)
- Applicant: Wandercraft SAS
- Decided: Oct 24, 2025 after 212 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: 7 generations back to DEN130034 (2014). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232077: Atalante X, Wandercraft SAS (2023) Summary page 6.

## Most influential descendants
- K260381: Eve (2026), 0 descendants of its own

## Indications for use
Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator for the following populations: * Individuals with hemiplegia due to cerebrovascular accident (CVA) * Individuals with spinal cord injuries at levels C4 to L5 (SCI) * Individuals with multiple sclerosis (MS) The operator must complete a training program prior to use of the device. Atalante X is intended to be used on adolescents of 18 years and older, and adults able to tolerate a stand-up position. The device is not intended for sports or stair climbing.

Source page: https://510kreport.com/device/K250904
Methodology: https://510kreport.com/methodology