PainChek

Primary DI
09360350000022
Brand
PainChek
Company
PAINCHEK LTD
Model
PainChek Adult Android
Device description
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.
Published
2026-05-18
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SGBPain Assessment Software In Non-Communicative Adults

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SGBPain Assessment Software In Non-Communicative AdultsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN240073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN240073000PainChek (PainChek Adult)Painchek Limited (Ltd.)2025-10-06SGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09360350000022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09360350000022093603500000229360350000022

GMDN Terms#

Term, Definition table
TermDefinition
Image-based pain-assessment softwareA software program designed to be used on an off-the-shelf smart device with a built-in camera (e.g., smartphone, tablet) to allow a healthcare provider/caregiver to obtain images/video of a patient to assess the patient’s level of pain; it is typically used to assess patients who cannot communicate effectively (e.g., children, patients with dementia). It typically uses artificial intelligence and is intended to analyse patient facial expressions, and capture non-facial pain-related features, to allow the computation of a pain score and assignment of a pain intensity; this data is communicated to a patient record or other medical data repository.

Regulatory Flags#

DUNS number
744664996
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09360350000015PainChekPainChek Adult iOS2026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09360350000015PainChekPAINCHEK LTDSGB2026-05-18