# K250405: Nerivio; Nerivio Infinity

- Pathway: 510(k) (Traditional)
- Applicant: Theranica Bio-Electronics, Ltd.
- Decided: May 14, 2025 after 90 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN180059 (2019). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241756: Nerivio; NerivioInfinity, Theranica Bio-Electronics, Ltd. (2024) Summary page 5.

## Recalls of this device
- Mar 23, 2026 · Class II · Z-2855-2026: Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

## Indications for use
Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 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. Nerivio Infinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 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/K250405
Methodology: https://510kreport.com/methodology