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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 K201824
Device Name Nerivio
Applicant
Theranica Bio-Electronics LTD.
4 Ha-Omanut St.
Netanya,  IL 4250438
Applicant Contact Alon Ironi
Correspondent
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number882.5899
Classification Product Code
QGT  
Date Received07/01/2020
Decision Date 10/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04161807
NCT04194008
Reviewed by Third Party No
Combination Product No
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