FDA.reportPublic FDA data

Psychophysiological biofeedback system

Definition
A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.
GUDID devices
149
Last updated
2026-08-08 10:09:05

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08592566001024TruScan Neurofeedback 24chDEYMED Diagnostic s.r.o.TS-NFB242019-07-18
08592566001048TruScan Neurofeedback 32chDEYMED Diagnostic s.r.o.TS-NFB322019-07-18
08592566001093Pair of Ear Electrodes Sn (Tin)DEYMED Diagnostic s.r.o.white, 1.5 m2023-06-12
08592566001109Pair of Ear Electrodes Sn (Tin)DEYMED Diagnostic s.r.o.white, 15 cm2023-06-12
08592566001116Pair of Ear Electrodes Sn (Tin)DEYMED Diagnostic s.r.o.blue, 1.5 m2023-06-12
08592566001147Disc Electrode 9mm Sn (Tin)DEYMED Diagnostic s.r.o.mix 5pcs2023-06-13
08592566001154Disc Electrode 9mm Sn (Tin)DEYMED Diagnostic s.r.o.mix 10pcs2023-06-13
08592566001161Disc Electrode 9mm Sn (Tin)DEYMED Diagnostic s.r.o.mix 25pcs2023-06-13
08592566001192Set for the application of EEG recording gelDEYMED Diagnostic s.r.o.2023-06-12
08592566001208Disposable blunted needlesDEYMED Diagnostic s.r.o.50 pcs2023-10-26
08592566419003TruScan Neurofeedback AdapterDEYMED Diagnostic s.r.o.41-9002023-10-26
08592566431395TruScan LT 24 Neurofeedback headboxDEYMED Diagnostic s.r.o.43-1392023-10-26
08592566432392TruScan LT 32 Neurofeedback headboxDEYMED Diagnostic s.r.o.43-2392023-10-26
08592566449000TruScan Neurofeedback optical cable V3.3LDEYMED Diagnostic s.r.o.44-9002023-10-26
08592566509001TruScan Neurofeedback AcquisitionDEYMED Diagnostic s.r.o.50-9002023-10-26
08592566509506TruScan Neurofeedback ExplorerDEYMED Diagnostic s.r.o.50-9502023-10-26
08592566629105FlexiCAPDEYMED Diagnostic s.r.o.XS (47 – 51 cm, green), 32 channels, layout 062023-06-12
08592566629112FlexiCAPDEYMED Diagnostic s.r.o.S (51 – 55 cm, yellow), 32 channels, layout 062023-06-12
08592566629129FlexiCAPDEYMED Diagnostic s.r.o.M (55 – 59 cm, red), 32 channels, layout 062023-06-12
08592566629136FlexiCAPDEYMED Diagnostic s.r.o.L (59 – 63 cm, blue), 32 channels, layout 062023-06-12
08592566629143FlexiCAPDEYMED Diagnostic s.r.o.XS (47 – 51 cm, green)2023-06-12
08592566629150FlexiCAPDEYMED Diagnostic s.r.o.S (51 – 55 cm, yellow)2023-06-12
08592566629167FlexiCAPDEYMED Diagnostic s.r.o.M (55 – 59 cm, red)2023-06-12
08592566629174FlexiCAPDEYMED Diagnostic s.r.o.L (59 – 63 cm, blue)2023-06-12
08592566629181Cable for connectionDEYMED Diagnostic s.r.o.32ch FlexiCap 62-91X2023-06-12
08592566629310Recording Cap G1DEYMED Diagnostic s.r.o.XS (18.5“ - 20“)2023-06-12
08592566629327Recording Cap G1DEYMED Diagnostic s.r.o.S (20“ - 21.5“)2023-06-12
08592566629334Recording Cap G1DEYMED Diagnostic s.r.o.M (21.5“ - 23“)2023-06-12
08592566629341Recording Cap G1DEYMED Diagnostic s.r.o.L (23“ - 25“)2023-06-12
08592566639005Ear Electrode Sn (Tin)DEYMED Diagnostic s.r.o.white, 1.5 m2023-10-26
08592566639012Ear Electrode Sn (Tin)DEYMED Diagnostic s.r.o.white, 15 cm2023-10-26
08592566639029Ear Electrode Sn (Tin)DEYMED Diagnostic s.r.o.blue, 1.5 m2023-10-26
08592566639036Quick Insert ElectrodeDEYMED Diagnostic s.r.o.2023-06-12
08592566639050SplitterDEYMED Diagnostic s.r.o.Y-Connector: 1F - 2M2023-06-12
08592566639067SplitterDEYMED Diagnostic s.r.o.X-Connector: 2M - 2F2023-06-12
08592566639142Body HarnessDEYMED Diagnostic s.r.o.XS2023-06-12
08592566639159Body HarnessDEYMED Diagnostic s.r.o.S/M2023-06-12
08592566639166Body HarnessDEYMED Diagnostic s.r.o.L2023-06-12
08592566639203Headbox Safety Ribbon Cable for Cap ConnectionDEYMED Diagnostic s.r.o.10 cm2023-06-12
08592566639210Headbox Safety Ribbon Cable for Cap ConnectionDEYMED Diagnostic s.r.o.100 cm2023-06-12
08592566639227Headbox Safety Ribbon Cable for Cap ConnectionDEYMED Diagnostic s.r.o.150 cm2023-06-12
08592566639234Headbox Safety Ribbon Cable for Cap ConnectionDEYMED Diagnostic s.r.o.50cm2023-10-26
08592566639258Disc Electrode 9mm Sn (Tin)DEYMED Diagnostic s.r.o.blue2023-06-12
08592566639265Disc Electrode 9mm Sn (Tin)DEYMED Diagnostic s.r.o.red2023-06-12
08592566639272Disc Electrode 9mm Sn (Tin)DEYMED Diagnostic s.r.o.yellow2023-06-12
08592566639289Disc Electrode 9mm Sn (Tin)DEYMED Diagnostic s.r.o.green2023-06-12
08592566639296Disc Electrode 9mm Sn (Tin)DEYMED Diagnostic s.r.o.white2023-06-12
08592566639302Wrist Band Electrode Sn(Tin)DEYMED Diagnostic s.r.o.red2023-06-12
08592566639319Wrist Band Electrode Sn(Tin)DEYMED Diagnostic s.r.o.yellow2023-06-12
08592566639340EEG cap strapDEYMED Diagnostic s.r.o.XS (green)2023-10-26
08592566639357EEG cap strapDEYMED Diagnostic s.r.o.S (yellow)2023-10-26
08592566639364EEG cap strapDEYMED Diagnostic s.r.o.M (red)2023-10-26
08592566639371EEG cap strapDEYMED Diagnostic s.r.o.L (blue)2023-10-26
08592566679001FlexiCAP electrode ring - rubberDEYMED Diagnostic s.r.o.white2023-10-26
08592566829109FlexiCAPDEYMED Diagnostic s.r.o.Size XS 47-51 cm, 18,5-20 in, layout 062023-10-26
08592566829116FlexiCAPDEYMED Diagnostic s.r.o.Size S 51-55 cm, 20-21,5 in, layout 062023-10-26
08592566829123FlexiCAPDEYMED Diagnostic s.r.o.Size M 55-59 cm, 21,5-23 in, layout 062023-10-26
08592566829130FlexiCAPDEYMED Diagnostic s.r.o.Size L 59-63 cm, 23-25 in, layout 062023-10-26
08592566829147FlexiCAPDEYMED Diagnostic s.r.o.Size XS 47-51 cm, 18,5-20 in2023-10-26
08592566829154FlexiCAPDEYMED Diagnostic s.r.o.Size S 51-55 cm, 20-21,5 in2023-10-26
08592566829161FlexiCAPDEYMED Diagnostic s.r.o.Size M 55-59 cm, 21,5-23 in2023-10-26
08592566829178FlexiCAPDEYMED Diagnostic s.r.o.Size L 59-63 cm, 23-25 in2023-10-26
08592566829314Recording Cap G1DEYMED Diagnostic s.r.o.XS (18.5“ - 20“)2023-10-26
08592566829321Recording Cap G1DEYMED Diagnostic s.r.o.S (20“ - 21.5“)2023-10-26
08592566829338Recording Cap G1DEYMED Diagnostic s.r.o.M (21.5“ - 23“)2023-10-26
08592566829345Recording Cap G1DEYMED Diagnostic s.r.o.L (23“ - 25“)2023-10-26
00860015825803JOGO-GxJogohealth, Inc.022026-07-27
07540191000678NeuroInfinitiThought Technology Ltd.SA75502026-07-06
50885380195554NTRAINERCardinal Health 200, LLC505NT2023-07-03
50885380195561NTRAINERCardinal Health 200, LLC510NT2023-07-03
50885380198791KangarooCardinal Health 200, LLC1000NT-T2025-03-12
B758000RDA483dorsaVi - V6 Overwrap AdhesivesDORSAVI LTDV6 Overwrap Adhesives2023-08-30
B758000RDA890dorsaVi - V6 EMG DAPDORSAVI LTDV6 EMG DAP2023-08-30
B758000RDA891dorsaVi - V6 Low Back AMI DAPDORSAVI LTDV6 Low Back AMI DAP2023-08-30
07290019255055SCENTIFIC Respiratory BiofeedbackAPPSCENT MEDICAL LTD22026-02-16
10885380198786KangarooCardinal Health 200, LLC1000NT-H2025-03-12
10885380198793KangarooCardinal Health 200, LLC1000NT-T2025-03-12
B185FS059370FST5Freespira, Inc.52025-01-23
09413000107500AxonEXSURGO LIMITEDiOS2025-01-15
00855846007245MyoPro 2x Assembly KitMyomo, Inc.Motion G Left - 30381 rev12024-12-11