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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 K232077
Device Name Atalante X
Applicant
Wandercraft SAS
88 rue de Rivoli
Paris,  FR 75004
Applicant Contact Matthieu Masselin
Correspondent
Wandercraft SAS
88 rue de Rivoli
Paris,  FR 75004
Correspondent Contact Maria Ida Iacono
Regulation Number890.3480
Classification Product Code
PHL  
Date Received07/13/2023
Decision Date 12/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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