Cleared Traditional

K230826 - Modius Sleep (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K230826 · Neurovalens , Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Oct 2023
Decision
217d
Days
Class 2
Risk

K230826 is an FDA 510(k) clearance for the Modius Sleep. Classified as Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (product code QJQ), Class II - Special Controls.

Submitted by Neurovalens , Ltd. (Portglenone, GB). The FDA issued a Cleared decision on October 27, 2023 after a review of 217 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 , Ltd. devices

Submission Details

510(k) Number K230826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2023
Decision Date October 27, 2023
Days to Decision 217 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 148d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04595968 Completed Interventional Industry-sponsored

Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control As a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus

A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Vestibular Nerve Stimulation (VeNS), Together with a Lifestyle Modification Program, Compared to a Sham Control with a Lifestyle Modification Program, As a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus

267
Patients (actual)
16
Sites
Treatment
Purpose
Triple
Masking
Condition studied Type 2 Diabetes
Study design Parallel
Eligibility All sexes · 22 Years+
Principal investigator Erik Viirre, MD PhD
Sponsor Neurovalens Ltd. (industry)
Started 2021-05-21 → Primary completion 2024-08-06
Primary outcome
Change in glycated hemoglobin (HbA1c)
Secondary outcome
Participants who achieve HbA1c targets
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov