510(k) DEN240073
DEN240073 is an FDA 510(k) premarket notification submitted by Painchek Limited (Ltd.) for the device "PainChek (PainChek Adult)". The FDA issued a decision of De Novo Granted on Oct 6, 2025. The device falls under product code SGB (Pain Assessment Software In Non-Communicative Adults), a Class II device regulated under 21 CFR 882.1472.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Oct 6, 2025
- Date Received
- Dec 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 patients 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.