# K260381: Eve

- Pathway: 510(k) (Traditional)
- Applicant: Wandercraft SAS
- Decided: Aug 3, 2026 after 179 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: 8 generations back to DEN130034 (2014). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250904: Atalante X, Wandercraft SAS (2025) Summary page 6.
- K173530: Indego (R), Parker-Hannifin Corporation (2018) Summary page 6.

## Indications for use
Eve - the Personal Exoskeleton by Wandercraft is intended to enable the user to perform walking functions and activities of daily living, hands-free, utilizing self-balancing technology, in home and community settings limited to indoor areas and open-air spaces that are part of a building's structure, under the supervision of a specially trained companion in accordance with the user assessment and training certification program. Eve is intended to be used by individuals with spinal cord injury at any level, able to operate the device with a controller. The Personal Exoskeleton is intended to be used on individuals of 18 years and older who are able to tolerate a standing position. Eve is not intended for sports or stair climbing.

Source page: https://510kreport.com/device/K260381
Methodology: https://510kreport.com/methodology