# K234029: CEFALY Connected - OTC, CEFALY Connected - Rx

- Pathway: 510(k) (Traditional)
- Applicant: Cefaly Technology
- Decided: Jul 18, 2024 after 211 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: 6 generations back to DEN120019 (2014). 6 ancestors in all.
1 later device descends 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)
- K212071: Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx, Cefaly Technology (2022) Summary page 5.

## Most influential descendants
- K254216: Enso for Migraine (2026), 0 descendants of its own

## Indications for use
Cefaly Connected - OTC is 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 Connected - Rx is 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/K234029
Methodology: https://510kreport.com/methodology