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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, Electrical, Transcutaneous, For Migraine
510(k) Number K254216
Device Name Enso for Migraine
Applicant
Hinge Health, Inc.
455 Market St.
Suite 700
San Francisco,  CA  94105
Applicant Contact Roop Pandher
Correspondent
Hinge Health, Inc.
455 Market St.
Suite 700
San Francisco,  CA  94105
Correspondent Contact Roop Pandher
Regulation Number882.5891
Classification Product Code
PCC  
Date Received12/29/2025
Decision Date 04/16/2026
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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