FDA device listing
B4C System,B4C System - Plastic casing (Model: BcAc-CASE-1000),B4C System - Wireless Adapter (Model: BcAc-DG-1000),B4C…
FDA device listing 1090548364 · Braincare Desenvolvimento e Inovacao Tecnologica S.A.
Key facts
| Proprietary names | B4C System,B4C System - Plastic casing (Model: BcAc-CASE-1000),B4C System - Wireless Adapter (Model: BcAc-DG-1000),B4C System - Wireless Sensor Charger (Model: BcAc-DCK-1000),B4C System - Wireless Sensor External Battery (Model: BcSs-BAT-1000 or BcSs-BATEX-1000),B4C System - Wireless Sensor Headband Set (Model: BcAc-AF-1000),B4C System - Wireless Sensor Headband Set (Model: BcAc-FU-1000),B4C… |
|---|---|
| Owner/operator | Braincare Desenvolvimento e Inovacao Tecnologica S.A. |
| Owner/operator number | 10061705 |
| Premarket submissions | K201989 |
| Product codes | GWM |
| Device names | GWM - Device, Monitoring, Intracranial Pressure |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.1620 |
| Review panels | Neurology |
| Registered establishments | BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A., Braincare USA Corp. |
| Establishment registrations | 3017180827, 3023074935 |
| FEI numbers | 3017180827, 3023074935 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database