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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
510(k) Number K250405
Device Name Nerivio; Nerivio Infinity
Applicant
Theranica Bio-Electronics, Ltd.
4 Ha-Omanut St.
Netanya,  IL 4250438
Applicant Contact Alon Ironi
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number882.5899
Classification Product Code
QGT  
Date Received02/13/2025
Decision Date 05/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT05464069
NCT05760638
NCT06738056
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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