Skip to contentDe Novo DEN240073
- Device
- PainChek (PainChek Adult)
- Contact
- caleb ng
- De Novo number
- DEN240073
- Product code
- SGB
- Regulation
- 882.1472
- Classification name
- pain assessment software in non-communicative adults
- Decision
- granted (DENG)
- Decision date
- 2025-10-06
- Date received
- 2024-12-11
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- SGB
- Device name
- Pain Assessment Software In Non-Communicative Adults
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.1472
- Implant
- N
- Life sustain/support
- N