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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 K250904
Device Name Atalante X
Applicant
Wandercraft SAS
88 Rue De Rivoli
Paris,  FR 75004
Applicant Contact Mélanie Combes
Correspondent
Wandercraft SAS
88 Rue De Rivoli
Paris,  FR 75004
Correspondent Contact Mélanie Combes
Regulation Number890.3480
Classification Product Code
PHL  
Date Received03/26/2025
Decision Date 10/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04187209
NCT05563402
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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