Data / Medical devices / United States / Braincare USA Corp.
Braincare USA Corp.: FDA-registered device maker in Johns Creek, GA, United States, 3 510(k) clearances
Braincare USA Corp. is registered with the FDA (registration 3023074935) in Johns Creek, GA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated July 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023074935
- Address
- 6470 E Johns Crossing Suite 160 Office 114, Johns Creek, GA, United States, 30097
- Owner or operator
- Braincare Desenvolvimento e Inovacao Tecnologica S.A. (10061705)
- Roles
- Complaint file establishment
- First device listed
- July 1, 2020
- Registered through
- 2026
- Brand names listed
- Adapter BcAc-MA-1003, Adapter BcAc-MA-1027, Adapter BcAc-MA-1028, Adapter BcAc-MA-1030, B4C System, B4C System - Addition of new sensor model (BcSs-PICNIW-2000), B4C System - Plastic casing (Model: BcAc-CASE-1000), B4C System - Plastic casing (Model: BcAc-CASE-2000) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| July 18, 2024 | K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | GWM | Substantially Equivalent | Braincare Desenvolvimento E Inovação Tecnológica S.A. | accessdata.fda.gov |
| October 8, 2021 | K201989 | B4C System | GWM | Substantially Equivalent | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | accessdata.fda.gov |
| October 17, 2019 | K182073 | BcSs-PICNI-2000 Sensor | GWM | Substantially Equivalent | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | accessdata.fda.gov |
Compare with other makers
Updated July 18, 2024. 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.