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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 Rd.
Portglenone,  GB BT44 8BP
Applicant Contact Jason Mckeown
Correspondent
Neurovalens Limited
8 Carmagrim Rd.
Portglenone,  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
Predetermined Change
Control Plan Authorized		 No
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