Cleared Traditional

K232253 - Modius Stress

K232253 is an FDA 510(k) clearance for Modius Stress, manufactured by Neurovalens Limited. The device is a Class 2 Neurology device with product code QJQ cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K232253 · Neurovalens Limited · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
243d
Days
Class 2
Risk

K232253 is an FDA 510(k) clearance for the Modius Stress. Classified as Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (product code QJQ), Class II - Special Controls.

Submitted by Neurovalens Limited (Portglenone, GB). The FDA issued a Cleared decision on March 27, 2024 after a review of 243 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 Neurovalens Limited devices

FDA 510(k) Submission Details - K232253

510(k) Number K232253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2023
Decision Date March 27, 2024
Days to Decision 243 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
94d slower than avg
Panel avg: 149d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QJQ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety

All 8
Devices cleared under the same product code (QJQ) and FDA review panel - the closest regulatory comparables to K232253.
Genesis Sleep
K252951 · Neurofield, Inc. · Dec 2025
Modius Sleep
K230826 · Neurovalens , Ltd. · Oct 2023
Cervella
K182311 · Innovative Neurological Devices, LLC · Mar 2019
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
K090052 · Johari Digital Healthcare , Ltd. · May 2009
ELEXOMA MEDIC
K070412 · Redplane AG · May 2008
CES ULTRA
K062284 · Neuro-Fitness, LLC · Apr 2007