Cleared Traditional

Milieve (YPS-301BD)

K233751 · Soterix Medical, Inc. · Neurology

Jun 2024

Decision

194d

Days

Class 2

Risk

About This 510(k) Submission

K233751 is an FDA 510(k) clearance for the Milieve (YPS-301BD), a Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (Class II — Special Controls, product code PCC), submitted by Soterix Medical, Inc. (Woodbridge, US). The FDA issued a Cleared decision on June 3, 2024, 194 days after receiving the submission on November 22, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5891.

Submission Details

510(k) Number	K233751 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2023
Decision Date	June 03, 2024
Days to Decision	194 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PCC — Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5891
Definition	Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin.