Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023074935

FEI Number

3023074935

Entity Name

Braincare USA Corp.

City/State/Country

Johns Creek, GA, US

Establishment Address

6470 E Johns Crossing, Suite 160 Office 114, Johns Creek, GA 30097, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Braincare Desenvolvimento e Inovacao Tecnologica S.A. (Owner Number: 10061705)

Owner / Operator Contact Address

Av Bruno Ruggiero Filho, 971, São Carlos, BR-SP 13562-420, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240821

PMA Number

N/A

All Registered 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 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 - Wireless Adapter (Model: BcAc-DG-1000) B4C System - Plastic casing (Model: BcAc-CASE-2000)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2020-07-01
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2021-11-10
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2024-07-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Braincare Desenvolvimento e Inovacao Tecnologica S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017180827	BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.	Sao Carlos Sao Paulo, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023074935. Last updated year: 2026. Please use registration number 3023074935 when referencing this establishment in official correspondence.