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510(k) DEN240073

PainChek (PainChek Adult) by Painchek Limited (Ltd.) — Product Code SGB

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
October 6, 2025
Date Received
December 11, 2024
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pain Assessment Software In Non-Communicative Adults
Device Class
Class II
Regulation Number
882.1472
Review Panel
NE
Submission Type

Pain assessment software in non-communicative adults is a prescription-only device that combines information from clinical pain domains to produce an output indicative of a patient’s current level of pain in conscious adult patients who are unable to communicate their current pain level. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic tool.