Companies / Theranica Bio-Electronics

Medical device company profile

Theranica Bio-Electronics

Developer of Nerivio, a prescription wearable for acute and preventive migraine treatment.

Manufacturer / DeveloperNeurology, Mental Health & PainNeural Interfaces & NeurostimulationPain ManagementCommercial-stage

Headquarters🇮🇱Netanya, Israel

FoundedNot confirmed

Commercial statusCommercially availableNerivio is available by prescription in the United States and selected international markets.

EmployeesNot confirmed

Estimated revenueNot confirmed

Disclosed fundingUS$45 million ^[15]Series C first closing announced August 29, 2022; not cumulative funding.

Official websitetheranica.com ↗

Company overview

Theranica develops non-invasive neuromodulation therapies for migraine and other pain conditions. Its Nerivio wearable is worn on the upper arm and controlled through a smartphone application. The U.S. business operates through Theranica USA.

Nerivio uses remote electrical neuromodulation to activate pain-modulation pathways. Current U.S. labeling covers prescription, self-administered acute and/or preventive migraine treatment in patients aged eight and older. The original 2019 De Novo authorization and subsequent indication expansions are distinct regulatory milestones.

^{[1][2][3][4][13][14][15]}

Leadership

3 people

Alon IroniCo-founder and Chief Executive Officer ^[14]

Ronen JashekCo-founder and Chief Operating Officer ^[14]

Slava BarabashCo-founder and Chief Technology Officer ^[14]

Products & regulatory status How does MedTechIndex get this information?

Summary

FDA granted Nerivio Migra’s De Novo request DEN180059 on May 20, 2019. Current manufacturer labeling covers acute and/or preventive migraine treatment in patients aged eight and older, reflecting subsequent indication expansions. ^[5][13]

Six subsequent 510(k) clearances are documented for the Nerivio family, including Nerivio Infinity. The latest matched decision is K250405, dated May 14, 2025. ^{[7][9][8][6][10][11]}

FDA lists an open Class II recall, Z-2855-2026, for specified Nerivio Infinity FGD000100 devices and firmware/app versions. The record concerns a charging-related overheating risk and describes firmware and app corrections. It does not identify the entire Nerivio portfolio as recalled. ^[12]

Regulatory snapshot How to read this snapshot

U.S. FDA

6
510(k) clearances: 1
De Novo grants: 0
PMA approvals: 1
Recall events

Latest recorded source review: 2026-10-30.

Scope: selected product families.

View 1 documented open recall event

Documented open FDA recall events
Recalled product / record	Initiated	Source
Nerivio Infinity FGD000100; specified firmware/app versionsZ-2855-2026	March 23, 2026	^[12]

Commercial portfolio snapshot

Documented commercial product families.

Prescription migraine neuromodulation wearable

Nerivio ↗

Smartphone-controlled upper-arm wearable that delivers remote electrical neuromodulation for acute and preventive migraine treatment. ^[13]

FDA-authorized; current labeling ages 8+

Prescription home-use treatment in the United States.

Activity & Milestones

1 events

2019-05-20 · Regulatory

Original Nerivio De Novo authorization

FDA granted DEN180059 for the original acute migraine device. ^[5]

15 Cited Sources

Accessed 10/30/2026

Last substantive review: 10/30/2026

[1] FDA 510(k) database — research search ↗U.S. Food and Drug Administration · regulatory databaseFDA database search page; not an individual device record.

[2] FDA enforcement reports database — research search ↗U.S. Food and Drug Administration · regulatory databaseFDA database search page; not an individual device record.

[3] FDA PMA database — research search ↗U.S. Food and Drug Administration · regulatory databaseFDA database search page; not an individual device record.

[4] FDA medical-device recall database — research search ↗U.S. Food and Drug Administration · regulatory databaseFDA database search page; not an individual device record.

[5] FDA De Novo decision DEN180059 ↗U.S. Food and Drug Administration · regulatory database

[6] FDA 510(k) decision K201824 ↗U.S. Food and Drug Administration · regulatory database

[7] FDA 510(k) decision K203181 ↗U.S. Food and Drug Administration · regulatory database

[8] FDA 510(k) decision K223169 ↗U.S. Food and Drug Administration · regulatory database

[9] FDA 510(k) decision K232152 ↗U.S. Food and Drug Administration · regulatory database

[10] FDA 510(k) decision K241756 ↗U.S. Food and Drug Administration · regulatory database

[11] FDA 510(k) decision K250405 ↗U.S. Food and Drug Administration · regulatory database

[12] FDA recall record 221248 ↗U.S. Food and Drug Administration · regulatory database

[13] Nerivio product and U.S. labeling ↗Theranica Bio-Electronics · company website

[14] Theranica and founders ↗Theranica Bio-Electronics · company website

[15] Series C first closing announcement ↗Theranica Bio-Electronics · company website