# DEN180059: Nerivio Migra

- Pathway: De Novo (Direct)
- Applicant: Theranica Bioelectronics, Ltd.
- Decided: May 20, 2019 after 195 days
- Product code: QGT (Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine)
- Device class: 2
- Regulation: 21 CFR 882.5899
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K201824: Nerivio (2020), 5 descendants of its own
- K203181: Nerivio, FGD000075-4.7 (2021), 4 descendants of its own
- K223169: Nerivio (2023), 3 descendants of its own
- K232152: NerivioInfinity (2023), 2 descendants of its own
- K241756: Nerivio; NerivioInfinity (2024), 1 descendant of its own

## Indications for use
The Nerivio Migra is indicated for acute treatment of migraine with or without aura in patients 18 years of age or older who do not have chronic migraine. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura.

Source page: https://510kreport.com/device/DEN180059
Methodology: https://510kreport.com/methodology