510(k) K250405

Device

Nerivio; Nerivio Infinity

Applicant

Theranica Bio-Electronics, Ltd.

510(k) number

K250405

Product code

QGT

Decision

Substantially Equivalent (SESE)

Decision date

2025-05-14

Date received

2025-02-13

Regulation

882.5899

Classification name

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Medical specialty

Neurology

Review panel

Neurology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N