Data / Medical devices / United Kingdom / Kneu Health Limited
Kneu Health Limited: FDA-registered device maker in London London, City of, United Kingdom, 2 510(k) clearances
Kneu Health Limited is registered with the FDA (registration 3032027298) in London London, City of, United Kingdom. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3032027298
- Address
- 22 Clerkenwell Green, London London, City of, United Kingdom, EC1R 0NA
- Owner or operator
- Kneu Health Ltd (10091292)
- Roles
- Specification developer
- First device listed
- August 13, 2024
- Registered through
- 2027
- Brand names listed
- Kneu Platform, Neu Platform
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computerized Cognitive Assessment Aid, Exempt | PTY | 2 | Specification developer | accessdata.fda.gov |
| Exerciser, Measuring | ISD | 2 | Specification developer | accessdata.fda.gov |
| Reminder, Medication | NXQ | 1 | Specification developer | accessdata.fda.gov |
| Transducer, Tremor | GYD | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 20, 2026 | K262515 | Kneu Platform (V2) | GYD | Substantially Equivalent | Kneu Health Digital , Ltd. | accessdata.fda.gov |
| April 25, 2025 | K250153 | Neu Platform | GYD | Substantially Equivalent | Neuhealth Digital , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Tremor
- All makers of Computerized Cognitive Assessment Aid, Exempt
- All makers of Exerciser, Measuring
- All makers of Reminder, Medication
Updated August 20, 2026. 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.