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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 K232152
Device Name NerivioInfinity
Applicant
Theranica Bioelectronics ltd
4 Ha-Omanutst. Poleg Industrial Park
Netanya,  IL 4250574
Applicant Contact Alon Ironi
Correspondent
Hogan Lovells US LLP
1735 Market Street, Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number882.5899
Classification Product Code
QGT  
Date Received07/19/2023
Decision Date 11/08/2023
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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