# K201895: Cefaly Dual

- Pathway: 510(k) (Traditional)
- Applicant: Cefaly Technology
- Decided: Sep 29, 2020 after 83 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: 4 generations back to DEN120019 (2014). 4 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173006: Cefaly Dual, Cefaly Technology (2017) Summary page 4.

## Most influential descendants
- 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
- K254216: Enso for Migraine (2026), 0 descendants of its own
- K232749: Doopang (2024), 0 descendants of its own
- K233751: Milieve (YPS-301BD) (2024), 0 descendants of its own

## Indications for use
The Cefaly® Dual is indicated for - The acute treatment of migraine with or without aura in patients 18 years of age or older. - The prophylactic treatment of episodic migraine in patients 18 years of age or older.

Source page: https://510kreport.com/device/K201895
Methodology: https://510kreport.com/methodology