# K233751: Milieve (YPS-301BD)

- Pathway: 510(k) (Traditional)
- Applicant: Soterix Medical, Inc.
- Decided: Jun 3, 2024 after 194 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201895: Cefaly Dual, Cefaly Technology (2020) Summary page 5.

## Indications for use
The Milieve 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/K233751
Methodology: https://510kreport.com/methodology