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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 K201473
Device Name ExoAtlet-II
Applicant
Exoatlet Asia Co. , Ltd.
4582 S. Ulster Streer, Suite 205
Denver,  CO  80237
Applicant Contact Bret Bostock
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison C Komiyama
Regulation Number890.3480
Classification Product Code
PHL  
Date Received06/03/2020
Decision Date 07/16/2021
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
Predetermined Change
Control Plan Authorized		 No
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