# PCC: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

- Device class: 2; regulation: 21 CFR 882.5891; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 162 days (middle half 88–261)
- Recalls: 0 (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)
- 2014: 1
- 2016: 1
- 2017: 2
- 2018: 1
- 2019: 1
- 2020: 1
- 2021: 4
- 2022: 1
- 2024: 5
- 2026: 1

## Most-cited predicates
- K201895: Cefaly Dual (2020), cited by 5
- K160237: Cefaly (2016), cited by 4
- K173006: Cefaly Dual (2017), cited by 3
- K171446: Cefaly Acute (2017), cited by 2
- DEN120019: Cefaly (2014), cited by 2
- K203419: Relivion (2021), cited by 1
- K234029: CEFALY Connected - OTC, CEFALY Connected - Rx (2024), cited by 1
- K211380: Elexir (2021), cited by 1
- K212071: Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx (2022), cited by 1
- K172450: TENS device-HeadaTerm, eEspress (2018), cited by 1

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