Cleared Traditional

ALLIVE

K192773 · Nu Eyne Co., Ltd. · Neurology

Dec 2019

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K192773 is an FDA 510(k) clearance for the ALLIVE, a Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (Class II — Special Controls, product code PCC), submitted by Nu Eyne Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on December 6, 2019, 67 days after receiving the submission on September 30, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5891.

Submission Details

510(k) Number	K192773 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2019
Decision Date	December 06, 2019
Days to Decision	67 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.