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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
510(k) Number K230826
Device Name Modius Sleep
Applicant
Neurovalens Ltd.
8 Carmagrim Road
Portglenone,  GB BT44 8BP
Applicant Contact Jason McKeown
Correspondent
Neurovalens Ltd.
8 Carmagrim Road
Portglenone,  GB BT44 8BP
Correspondent Contact Jason McKeown
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received03/24/2023
Decision Date 10/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04595968
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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