# K241756: Nerivio; NerivioInfinity

- Pathway: 510(k) (Traditional)
- Applicant: Theranica Bio-Electronics, Ltd.
- Decided: Oct 8, 2024 after 112 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: 5 generations back to DEN180059 (2019). 5 ancestors in all.
1 later device descends 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)
- K232152: NerivioInfinity, Theranica Bioelectronics, Ltd. (2023) Summary page 5.
- K223169: Nerivio, Theranica Bioelectronics, Ltd. (2023) Summary page 5.

## Most influential descendants
- 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 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. The Neriviolnfinity 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/K241756
Methodology: https://510kreport.com/methodology