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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K233784
Device Name ENSO (Model 2)
Applicant
Hinge Health, Inc.
455 Market Street, Suite 700
San Francisco,  CA  94105
Applicant Contact Brandon Casa de Calvo
Correspondent
EBG Advisors, Inc.
1227 25th Street, NW
Suite 700
Washington,  DC  20037
Correspondent Contact Dawn Norman
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received11/27/2023
Decision Date 02/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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