# K212106: Relivion

- Pathway: 510(k) (Special)
- Applicant: Neurolief, Ltd.
- Decided: Aug 2, 2021 after 27 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.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203419: Relivion, Neurolief, Ltd. (2021) Summary page 4.

## Indications for use
The Relivion® transcutaneous electrical nerve stimulator is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is a prescription device to be self-used at home.

Source page: https://510kreport.com/device/K212106
Methodology: https://510kreport.com/methodology