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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name cranial electrotherapy stimulator for weight management
De Novo Number DEN240076
Device Name Modius Lean
Requester
neurovalens limited
8 carmagrim rd.
portglenone,  GB bt44 8bp
Contact jason mckeown
Regulation Number876.5984
Classification Product Code
SFW  
Date Received12/18/2024
Decision Date 10/17/2025
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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