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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 K232253
Device Name Modius Stress
Applicant
Neurovalens Limited
8 Carmagrim Road
Ballymena,  GB BT44 8BP
Applicant Contact Jason Mckeown
Correspondent
Neurovalens Limited
8 Carmagrim Road
Ballymena,  GB BT44 8BP
Correspondent Contact Jason Mckeown
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received07/28/2023
Decision Date 03/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT05845658
NCT05907967
Reviewed by Third Party No
Combination Product No
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