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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 K203181
Device Name Nerivio, FGD000075-4.7
Applicant
Theranica Bioelectronics , Ltd.
4 Ha-Omanut St. Poleg Industrial Park
Netanya,  IL 4250574
Applicant Contact Alon Ironi
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number882.5899
Classification Product Code
QGT  
Date Received10/26/2020
Decision Date 01/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04089761
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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