# QGT: Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

- Device class: 2; regulation: 21 CFR 882.5899; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 112 days (middle half 90–112)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2019: 1
- 2020: 1
- 2021: 1
- 2023: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- K223169: Nerivio (2023), cited by 2
- K232152: NerivioInfinity (2023), cited by 1
- K201824: Nerivio (2020), cited by 1
- K241756: Nerivio; NerivioInfinity (2024), cited by 1
- DEN180059: Nerivio Migra (2019), cited by 1
- K203181: Nerivio, FGD000075-4.7 (2021), cited by 1

Source page: https://510kreport.com/product-code/QGT
Data by year (CSV): https://510kreport.com/product-code/QGT.csv