# K223169: Nerivio

- Pathway: 510(k) (Traditional)
- Applicant: Theranica Bioelectronics, Ltd.
- Decided: Feb 6, 2023 after 118 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: 3 generations back to DEN180059 (2019). 3 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K203181: Nerivio, FGD000075-4.7, Theranica Bioelectronics, Ltd. (2021) Summary page 4.

## Most influential descendants
- 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 indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 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 for acute treatment, or every other day for preventive treatment.

Source page: https://510kreport.com/device/K223169
Methodology: https://510kreport.com/methodology