# K212071: Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx

- Pathway: 510(k) (Traditional)
- Applicant: Cefaly Technology
- Decided: Dec 13, 2022 after 529 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: 5 generations back to DEN120019 (2014). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 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 5.
- K201895: Cefaly Dual, Cefaly Technology (2020) Summary page 5.

## Most influential descendants
- K234029: CEFALY Connected - OTC, CEFALY Connected - Rx (2024), 1 descendant of its own
- K254216: Enso for Migraine (2026), 0 descendants of its own

## Indications for use
Cefaly Dual Connected - OTC and Cefaly Dual Enhanced with RFID - OTC are indicated for: 1. Acute treatment of migraine with or without aura in patients 18 years of age or older 2. Preventative treatment of migraine in patients 18 years of age or older Cefaly Dual Connected - Rx and Cefaly Dual Enhanced With RFID - Rx are indicated for: 1. Acute treatment of migraine with or without aura in patients 18 years of age or older 2. Prophylactic treatment of migraine in patients 18 years of age or older

Source page: https://510kreport.com/device/K212071
Methodology: https://510kreport.com/methodology