510(k) K232152

Device

NerivioInfinity

Applicant

Theranica Bioelectronics , Ltd.

510(k) number

K232152

Product code

QGT

Decision

Substantially Equivalent (SESE)

Decision date

2023-11-08

Date received

2023-07-19

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

No