Cleared Traditional

Modius Stress

K232253 · Neurovalens Limited · Neurology
Mar 2024
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K232253 is an FDA 510(k) clearance for the Modius Stress, a Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (Class II — Special Controls, product code QJQ), submitted by Neurovalens Limited (Portglenone, GB). The FDA issued a Cleared decision on March 27, 2024, 243 days after receiving the submission on July 28, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5800.

Submission Details

510(k) Number K232253 FDA.gov
FDA Decision Cleared 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

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