PainChek Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30225183663022518366PainChek Ltd.1N2026-01-01Suite 401, 35 Lime Street Sydney New South Wales AU 2000

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3441821848866423DEN240073PainChek (PainChek Adult)SGB2025-10-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SGB12025-10-06

GUDID#

PainChek - The PainChek® App is a mobile application that uses facial detection and analysis technology to detect facial features indicative of the presence of pain and then combines these data with non-facial pain features inputted by the User through a series of digital checklists to confirm the presence and intensity of pain. The PainChek® App is downloaded from the Apple App Store and it is generally used in much the same way as any other App. PainChek® Adult is intended to be used by medical doctors, registered nurses, licensed practical and vocational nurses, certified nursing assistants, clinical psychologists, physical therapists and occupational therapists to assess pain in non-verbal people with moderate to severe dementia in nursing homes.Indications for UsePainChek® is an observational pain assessment software application used to assist healthcare professionals in the assessment of pain in non-verbal Residents who have been diagnosed with moderate to severe dementia and who are living in nursing homes. Specifically, PainChek® 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 theindicated population.

PAINCHEK LTD

2026-05-18

PainChek - The PainChek® App is a mobile application that uses facial detection and analysis technology to detect facial features indicative of the presence of pain and then combines these data with non-facial pain features inputted by the User through a series of digital checklists to confirm the presence and intensity of pain. The PainChek® App is downloaded from the Google Play Store and it is generally used in much the same way as any other App. PainChek® Adult is intended to be used by medical doctors, registered nurses, licensed practical and vocational nurses, certified nursing assistants, clinical psychologists, physical therapists and occupational therapists to assess pain in non-verbal people with moderate to severe dementia in nursing homes. Indications for Use PainChek® is an observational pain assessment software application used to assist healthcare professionals in the assessment of pain in non-verbal Residents who have been diagnosed with moderate to severe dementia and who are living in nursing homes. Specifically, PainChek® 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.

PAINCHEK LTD

2026-05-18