BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Braincare USA Corp.

    Reg #: 3023074935 · FEI: 3023074935 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    1

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    Braincare USA Corp.
    Registration Number
    3023074935
    FEI Number
    3023074935
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6470 E Johns Crossing, Suite 160 Office 114
    City
    Johns Creek
    State
    GA
    ZIP
    30097
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182073

    Owner / Operator

    Firm Name
    Braincare Desenvolvimento e Inovacao Tecnologica S.A.
    Operator Number
    10061705
    Address
    Av Bruno Ruggiero Filho, 971
    City
    São Carlos
    State
    Sao Paulo
    Postal Code
    13562-420
    Country
    BR

    Products

    Device Name Product Code
    Device, Monitoring, Intracranial Pressure GWM

    Proprietary Names

    Braincare Wired System Headband Set Braincare Adapter Cable BcAc-MA-1030 Adapter BcAc-MA-1030 Braincare Adapter Cable BcAc-MA-1028 Braincare Adapter Cable BcAc-MA-1003 BcSs-PICNI-2000 Sensor Braincare Adapter Cable BcAc-MA-1027 Adapter BcAc-MA-1003 Braincare Wired Sensor Adapter BcAc-MA-1027 Adapter BcAc-MA-1028 Sensor BcSs-PICNI-2000 Braincare BcSs-PICNI- 2000 Sensor B4C System - Wireless Sensor Charger (Model: BcAc-DCK-1000) B4C System - Wireless Sensor Headband Set (Model: BcAc-AF-1000) B4C System - Wireless Adapter (Model: BcAc-DG-1000) B4C System B4C System - Wireless Sensor (Model: BCSs-PICNIW-1000) B4C System - Wireless Sensor External Battery (Model: BcSs-BAT-1000 or BcSs-BATEX-1000) B4C System - Plastic casing (Model: BcAc-CASE-1000) B4C System - Wireless Sensor Headband Set (Model: BcAc-FU-1000) B4C System - Wireless Sensor (Model: BCSs-PICNIW-2000) B4C System - Wireless Sensor Headband (Model: BcAc-AF-2000) B4C System - Wireless Sensor Charger (Model: BcAc-DCK-2000) B4C System - Addition of new sensor model (BcSs-PICNIW-2000) B4C System - Plastic casing (Model: BcAc-CASE-2000)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198