Data / Medical devices / Sweden / Braincool AB
Braincool AB: FDA-registered device maker in Lund Skane, Sweden, 2 510(k) clearances
Braincool AB is registered with the FDA (registration 3014426939) in Lund Skane, Sweden. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 14, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014426939
- Address
- Scheelevagen 2, Lund Skane, Sweden, 22381
- Owner or operator
- BrainCool AB (10058195)
- Roles
- Manufacturer
- First device listed
- July 26, 2018
- Registered through
- 2026
- Brand names listed
- IQool Warm System, The Cooral System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intraoral Cooling Device | QUA | 2 | Manufacturer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | 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 14, 2022 | DEN210027 | The Cooral System | QUA | Unknown | Braincool AB | accessdata.fda.gov |
| May 18, 2018 | K180375 | The IQoolTM Warm System | DWJ | Substantially Equivalent | Braincool AB | accessdata.fda.gov |
Compare with other makers
Updated October 14, 2022. 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.