Data / Medical devices / France / Wandercraft
Wandercraft: FDA-registered device maker in Paris Ile-de-France, France, 4 510(k) clearances
Wandercraft is registered with the FDA (registration 3015000676) in Paris Ile-de-France, France. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated August 3, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015000676
- Address
- 23-23 bis avenue d'Italie, Paris Ile-de-France, France, 75013
- Owner or operator
- Wandercraft (10087464)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 2, 2023
- Registered through
- 2026
- Brand names listed
- Atalante, Atalante X, Eve
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Exoskeleton | PHL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 3, 2026 | K260381 | Eve | PHL | Substantially Equivalent | Wandercraft SAS | accessdata.fda.gov |
| October 24, 2025 | K250904 | Atalante X | PHL | Substantially Equivalent | Wandercraft SAS | accessdata.fda.gov |
| December 13, 2023 | K232077 | Atalante X | PHL | Substantially Equivalent | Wandercraft SAS | accessdata.fda.gov |
| December 29, 2022 | K221859 | Atalante | PHL | Substantially Equivalent | Wandercraft SAS | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 3, 2025 | 96635 | Class II | Ongoing | Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator. | Potential for exoskeleton to lose lateral balance and cause patient to fall. | accessdata.fda.gov |
Compare with other makers
Updated August 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.