RONAN MEDICAL LLC

FDA Device Registration & Listing · Colorado Springs, CO, US · Registration 3015497638

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015497638
FEI Number
3015497638
Entity Name
RONAN MEDICAL LLC
City/State/Country
Colorado Springs, CO, US
Establishment Address
3630 Sinton Road, Suite 100, Colorado Springs, CO 80907, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Ronan Medical (Owner Number: 10060568)
Owner / Operator Contact Address
3630 Sinton Road, Suite 100, Colorado Springs, CO 80907, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

FlexiCAP TruScan Neurofeedback optical cable V3.3L Recording Cap G1 TruScan Neurofeedback Acquisition Body Harness Splitter Cable for connection TruScan Neurofeedback Explorer Quick Insert Electrode Disc Electrode 9mm Sn (Tin) Deymed Li-ion Battery FlexiCAP electrode ring - rubber Headbox Safety Ribbon Cable for Cap Connection Pair of Ear Electrodes Sn (Tin) Disposable blunted needles Wrist Band Electrode Sn(Tin) Set for the application of EEG recording gel TruScan Neurofeedback Adapter Ear Electrode Sn (Tin) EEG cap strap TruScan LT 32 Neurofeedback headbox TruScan Neurofeedback 32ch TruScan Neurofeedback 24ch TruScan LT 24 Neurofeedback headbox

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HCC Device, Biofeedback Neurology Class 2 882.5050 2019-05-28

Official Correspondent

Doug Youngberg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ronan Medical
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015497638. Last updated year: 2026. Please use registration number 3015497638 when referencing this establishment in official correspondence.
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