Nerivio

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Theranica Bio-Electronics LTD.

The following data is part of a premarket notification filed by Theranica Bio-electronics Ltd. with the FDA for Nerivio.

Pre-market Notification Details

Device IDK201824
510k NumberK201824
Device Name:Nerivio
ClassificationDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Applicant Theranica Bio-Electronics LTD. 4 Ha-Omanut St. Netanya,  IL 4250438
ContactAlon Ironi
CorrespondentJanice Hogan
Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia,  PA  19103
Product CodeQGT  
CFR Regulation Number882.5899 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-01
Decision Date2020-10-23

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