Cleared Traditional

K062284 - CES ULTRA
(FDA 510(k) Clearance)

K062284 · Neuro-Fitness, LLC · Neurology
Apr 2007
Decision
241d
Days
Class 2
Risk

K062284 is an FDA 510(k) clearance for the CES ULTRA, a Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (Class II — Special Controls, product code QJQ), submitted by Neuro-Fitness, LLC (Snoqualmie, US). The FDA issued a Cleared decision on April 5, 2007, 241 days after receiving the submission on August 7, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5800.

Submission Details

510(k) Number K062284 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2006
Decision Date April 05, 2007
Days to Decision 241 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