Cleared Traditional

Modius Sleep

K230826 · Neurovalens , Ltd. · Neurology
Oct 2023
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K230826 is an FDA 510(k) clearance for the Modius Sleep, a Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (Class II — Special Controls, product code QJQ), submitted by Neurovalens , Ltd. (Portglenone, GB). The FDA issued a Cleared decision on October 27, 2023, 217 days after receiving the submission on March 24, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5800.

Submission Details

510(k) Number K230826 FDA.gov
FDA Decision Cleared 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

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