# K192773: Allive

- Pathway: 510(k) (Traditional)
- Applicant: Nu Eyne Co., Ltd.
- Decided: Dec 6, 2019 after 67 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.
No later device cites it as a predicate yet.
0 of 3 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 5.

## Indications for use
The Allive is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

Source page: https://510kreport.com/device/K192773
Methodology: https://510kreport.com/methodology