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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 pain assessment software in non-communicative adults
De Novo Number DEN240073
Device Name PainChek (PainChek Adult)
Requester
painchek limited (ltd.)
suite 401, 35 lime st.
sydney,  AU 2000
Contact caleb ng
Regulation Number882.1472
Classification Product Code
SGB  
Date Received12/11/2024
Decision Date 10/06/2025
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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