# DEN240073: PainChek  (PainChek Adult)

- Pathway: De Novo (Direct)
- Applicant: Painchek Limited (Ltd.)
- Decided: Oct 6, 2025 after 299 days
- Product code: SGB (Pain Assessment Software In Non-Communicative Adults)
- Device class: 2
- Regulation: 21 CFR 882.1472
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
PainChek Adult is an observational pain assessment software application used to assist healthcare professionals in the assessment of pain in non-verbal patients who have been diagnosed with moderate to severe dementia and who are living in nursing homes. Specifically, PainChek Adult is intended to be used by trained medical doctors, nurses, licensed practical and vocational nurses, certified nursing assistants, clinical psychologists, physical therapists and occupational therapists to assess pain in the indicated population.

Source page: https://510kreport.com/device/DEN240073
Methodology: https://510kreport.com/methodology