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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Exoskeleton
510(k) Number K260381
Device Name Eve
Applicant
Wandercraft SAS
88 Rue De Rivoli
Paris,  FR 75004
Applicant Contact Maria Ida Iacono
Correspondent
Wandercraft SAS
88 Rue De Rivoli
Paris,  FR 75004
Correspondent Contact Maria Ida Iacono
Regulation Number890.3480
Classification Product Code
PHL  
Date Received02/05/2026
Decision Date 08/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Clinical Trials NCT06777576
NCT06814015
NCT07222033
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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