Data / Medical devices / Australia / PainChek Ltd.
PainChek Ltd.: FDA-registered device maker in Sydney New South Wales, Australia, 1 510(k) clearance
PainChek Ltd. is registered with the FDA (registration 3022518366) in Sydney New South Wales, Australia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022518366
- Address
- Suite 401, 35 Lime Street, Sydney New South Wales, Australia, 2000
- Owner or operator
- PainChek Ltd. (10094224)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 19, 2025
- Registered through
- 2026
- Brand names listed
- PainChek Adult
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pain Assessment Software In Non-Communicative Adults | SGB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 6, 2025 | DEN240073 | PainChek (PainChek Adult) | SGB | Unknown | Painchek Limited (Ltd.) | accessdata.fda.gov |
Updated October 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.