Cleared Traditional

Cervella

K182311 · Innovative Neurological Devices, LLC · Neurology

Mar 2019

Decision

195d

Days

Class 2

Risk

About This 510(k) Submission

K182311 is an FDA 510(k) clearance for the Cervella, a Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (Class II — Special Controls, product code QJQ), submitted by Innovative Neurological Devices, LLC (Carmel, US). The FDA issued a Cleared decision on March 7, 2019, 195 days after receiving the submission on August 24, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5800.

Submission Details

510(k) Number	K182311 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2018
Decision Date	March 07, 2019
Days to Decision	195 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QJQ — Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5800
Definition	To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety