Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012168464

FEI Number

3012168464

Entity Name

DEYMED DIAGNOSTIC S.R.O.

City/State/Country

Hronov Nachod, CZ

Establishment Address

Kudrnacova 533, Hronov Nachod 54931, CZ

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DEYMED Diagnostic s.r.o. (Owner Number: 10060567)

Owner / Operator Contact Address

Kudrnacova 533, Hronov, CZ-523 54931, CZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TruScan LT 24 Neurofeedback headbox Deymed Li-ion Battery Splitter Quick Insert Electrode TruScan Neurofeedback 32ch TruScan Neurofeedback Acquisition TruScan Neurofeedback 24ch FlexiCAP EEG cap strap Ear Electrode Sn (Tin) Pair of Ear Electrodes Sn (Tin) TruScan LT 32 Neurofeedback headbox TruScan Neurofeedback Adapter TruScan Neurofeedback optical cable V3.3L Disposable blunted needles Disc Electrode 9mm Sn (Tin) Headbox Safety Ribbon Cable for Cap Connection Recording Cap G1 Body Harness Cable for connection FlexiCAP electrode ring - rubber TruScan Neurofeedback Explorer Wrist Band Electrode Sn(Tin) Set for the application of EEG recording gel Liquid cooling DuoMAG NL Stimulation coil DuoMAG 60BF-NL Magnetic stimulator DuoMAG XT-NL Table MagCart NL DuoMAG NL

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
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2024-02-22
QPL	Electromagnetic Stimulator, Pain Relief	Neurology	Class 2	882.5890	2024-02-22

Official Correspondent

Kamil Holub

US Agent Details

Robert Packard Business: Medical Device Academy Incorporated Email: rob@fdaestar.com Phone: (802) 2581881

Related Public Records

Same Entity

DEYMED Diagnostic s.r.o.

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
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29

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3038620647	KISO EHF	Reykjavik, IS
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 3012168464. Last updated year: 2026. Please use registration number 3012168464 when referencing this establishment in official correspondence.