Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006789226

FEI Number

3006789226

Entity Name

CONTROL BIONICS INC.

City/State/Country

Milford, OH, US

Establishment Address

745 Center St Ste 303, Milford, OH 45150, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

CONTROL BIONICS (Owner Number: 9092699)

Owner / Operator Contact Address

745 CENTER ST., SUITE 303, Milford, OH 45150, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NeuroNode System NeuroEDUCATOR UNO TOUCH Eyegaze DUO NeuroNode Speech Generator NeuroSwitch NeuroNode Trilogy UNO TOUCH OMNI NeuroNode DUO NeuroSwitch NeuroNode NeuroNode Speech Generator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2014-12-22
ILQ	System, Communication, Powered	Physical Medicine	Class 2	890.3710	2006-09-21
IQA	System, Environmental Control, Powered	Physical Medicine	Class 2	890.3725	2006-09-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CONTROL BIONICS

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2016	Lifeline Systems, Incorporated	2	Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.

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3005196642	HARMONIC ENERGETIC TECHNOLOGIES, LLC	Liverpool, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006789226. Last updated year: 2026. Please use registration number 3006789226 when referencing this establishment in official correspondence.