Cleared Traditional

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

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K062284 is an FDA 510(k) clearance for the CES ULTRA. Classified as Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (product code QJQ), Class II - Special Controls.

Submitted by Neuro-Fitness, LLC (Snoqualmie, US). The FDA issued a Cleared decision on April 5, 2007 after a review of 241 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5800 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neuro-Fitness, LLC devices

Submission Details

510(k) Number K062284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 148d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5800
Definition To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.