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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K230997
Device Name EvoWalk 1.0 System
Applicant
Evolution Devices, Inc.
1111 Broadway Floor 3,
Oakland,  CA  94607
Applicant Contact Pierluigi Mantovani
Correspondent
Evolution Devices, Inc.
1111 Broadway Floor 3,
Oakland,  CA  94607
Correspondent Contact Pierluigi Mantovani
Regulation Number882.5810
Classification Product Code
GZI  
Date Received04/07/2023
Decision Date 12/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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