510(k) · Cleared
ClearedEve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wandercraft SAS · PHL Powered Exoskeleton
Cleared on Aug 3, 2026 as substantially equivalent to K250904 (Wandercraft SAS, 2025) and 1 other predicate after a 179-day review. Its family tree reaches back 8 generations to 2014.
- Decided
- Aug 3, 2026
- Review
- 179 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to DEN130034 (2014). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backDEN130034 RewalkArgo Medical Technologies, Inc. · 2014
- 7 generations backK143690 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- 6 generations backK161443 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- 5 generations backK171334 IndegoParker Hannifin Corporation · 2017
- 4 generations backK173530 Indego (R)Parker-Hannifin Corporation · 2018
- 3 generations backK221859 AtalanteWandercraft SAS · 2022 · Recalled
- 2 generations backK232077 Atalante XWandercraft SAS · 2023
- 1 generation backK250904 Atalante XWandercraft SAS · 2025
- This deviceK260381 EveWandercraft SAS · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | DEN130034 | Rewalk | Argo Medical Technologies, Inc. | 2014 | — |
| −7 | K143690 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| −6 | K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| −5 | K171334 | Indego | Parker Hannifin Corporation | 2017 | — |
| −4 | K173530 | Indego (R) | Parker-Hannifin Corporation | 2018 | — |
| −3 | K221859 | Atalante | Wandercraft SAS | 2022 | 1 |
| −2 | K232077 | Atalante X | Wandercraft SAS | 2023 | — |
| −1 | K250904 | Atalante X | Wandercraft SAS | 2025 | — |
| 0 (this device) | K260381 | Eve | Wandercraft SAS | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PHL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PHL device
- #1 K250904 Atalante Xscore 15.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K250904 | Atalante XSummary page 6…Device Secondary Predicate Device Device name Atalante X Indego® 510(K) number K250904 K173530 Regulation Number 21 CFR 890.3480 21 CFR 890.3480… | 2025 |
| * | K173530 | Indego (R)Summary page 6…Predicate Device Device name Atalante X Indego® 510(K) number K250904 K173530 Regulation Number 21 CFR 890.3480 21 CFR 890.3480 Regulation Name… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All PHL devicesPHL Powered Exoskeleton: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PHL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHL
177in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHL
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHL
6in 2025
MAUDE reports naming product code PHL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 4 | 145 | 0 | 4 |
| 2017 | 2 | — | 1 | 8 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 4 | 110 | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 3 | 177 | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 2 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (118 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260381: Eve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260381
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026