# K201824: Nerivio

- Pathway: 510(k) (Traditional)
- Applicant: Theranica Bio-Electronics, Ltd.
- Decided: Oct 23, 2020 after 114 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
Longest line of descent: 1 generation back to DEN180059 (2019). 1 ancestor in all.
5 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)
- DEN180059: Nerivio Migra, Theranica Bioelectronics, Ltd. (2019) Summary page 4.

## Most influential descendants
- 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
- K250405: Nerivio; Nerivio Infinity (2025), 0 descendants of its own

## Indications for use
The Nerivio is intended for acute treatment of migraine with or without aura in patients 18 years of age or older. 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/K201824
Methodology: https://510kreport.com/methodology