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Data / Medical devices / United States / Wandercraft Incorporated

Wandercraft Incorporated: FDA-registered device maker in New York, NY, United States, 4 510(k) clearances

Wandercraft Incorporated is registered with the FDA (registration 3034724466) in New York, NY, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated August 3, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3034724466
Address
345 Park Ave S, New York, NY, United States, 10010
Owner or operator
Wandercraft (10087464)
Roles
Manufacturer
First device listed
March 2, 2023
Registered through
2026
Brand names listed
Atalante, Atalante X, Eve

Devices it lists

DeviceProduct codeClassRoleSource
Powered ExoskeletonPHL2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 3, 2026K260381EvePHLSubstantially EquivalentWandercraft SASaccessdata.fda.gov
October 24, 2025K250904Atalante XPHLSubstantially EquivalentWandercraft SASaccessdata.fda.gov
December 13, 2023K232077Atalante XPHLSubstantially EquivalentWandercraft SASaccessdata.fda.gov
December 29, 2022K221859AtalantePHLSubstantially EquivalentWandercraft SASaccessdata.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.