510(k) K241756

Device

Nerivio; NerivioInfinity

Applicant

Theranica Bio-Electronics, Ltd.

510(k) number

K241756

Product code

QGT

Decision

Substantially Equivalent (SESE)

Decision date

2024-10-08

Date received

2024-06-18

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