# K171446: Cefaly Acute

- Pathway: 510(k) (Traditional)
- Applicant: Cefaly Technology
- Decided: Sep 15, 2017 after 122 days
- Product code: PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine)
- Device class: 2
- Regulation: 21 CFR 882.5891
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN120019 (2014). 2 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160237: Cefaly, Cefaly Technology (2016) Summary page 4.

## Most influential descendants
- K173006: Cefaly Dual (2017), 10 descendants of its own
- K201895: Cefaly Dual (2020), 7 descendants of its own
- K212071: Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx (2022), 2 descendants of its own
- K234029: CEFALY Connected - OTC, CEFALY Connected - Rx (2024), 1 descendant of its own
- K211380: Elexir (2021), 1 descendant of its own

## Indications for use
Cefaly® Acute is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older.

Source page: https://510kreport.com/device/K171446
Methodology: https://510kreport.com/methodology