Cleared Special

Relivion

K212106 · Neurolief , Ltd. · Neurology

Aug 2021

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K212106 is an FDA 510(k) clearance for the Relivion, a Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (Class II — Special Controls, product code PCC), submitted by Neurolief , Ltd. (Netanya, IL). The FDA issued a Cleared decision on August 2, 2021, 27 days after receiving the submission on July 6, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5891.

Submission Details

510(k) Number	K212106 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2021
Decision Date	August 02, 2021
Days to Decision	27 days
Submission Type	Special
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.