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
141
Last updated
2026-02-25 21:47:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
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
00855846007252MyoPro 2x Assembly KitMyomo, Inc.Motion G Right - 30382 rev12024-12-11
00855846007214MyoPro 2xMyomo, Inc.Motion G Left - 29857 rev12024-09-20
00855846007221MyoPro 2xMyomo, Inc.Motion G Right - 29858 rev12024-09-20
00855846007238Mobile Arm Rehabilitation Kit version 2 (MARK2)Myomo, Inc.MARK2 298602024-10-11
00855846007191Mobile Arm Rehabilitation Kit version 2 (MARK2)Myomo, Inc.MARK2 298602024-10-11
00855846007177MyoPro 2xMyomo, Inc.Motion G Left - 29857 rev12024-09-20
00855846007184MyoPro 2xMyomo, Inc.Motion G Right - 29858 rev12024-09-20
00851679007360Trigno Avanti SensorDELSYS, INC.SP-W112024-05-06
00851679007377Trigno CentroDELSYS, INC.SP-W102024-05-06
00851679007384Trigno Charge-16DELSYS, INC.SP-W092024-05-06
00851679007407Trigno Avanti Sensor, 4-PackDELSYS, INC.SP-W112024-05-06
00851679007391Trigno Wireless Biofeedback SystemDELSYS, INC.DS-T042024-04-12
07540191000630Resilience – By Inner Armor App iOSTechnologie de Pensée LtéeSA45152024-04-09
07290019736004PrismGRAYMATTERS HEALTH LTD1.02024-01-03
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
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
08592566639234Headbox Safety Ribbon Cable for Cap ConnectionDEYMED Diagnostic s.r.o.50cm2023-10-26
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
08592566001024TruScan Neurofeedback 24chDEYMED Diagnostic s.r.o.TS-NFB242019-07-18
08592566001048TruScan Neurofeedback 32chDEYMED Diagnostic s.r.o.TS-NFB322019-07-18
B758000VMPLU0ViMove+DORSAVI LTD000VMPLU02023-08-30
B75800RDA445dorsaVi - V6 Overwrap AdhesivesDORSAVI LTDV6 Overwrap Adhesives2023-08-30
B75800RDA865dorsaVi - V6 EMG DAPDORSAVI LTDV6 EMG DAP2023-08-30
B75800RDA866dorsaVi - V6 Low Back AMI DAPDORSAVI LTDV6 Low Back AMI DAP2023-08-30
B185SM40500FreespiraFreespira, Inc.32023-08-25
B75800003563030 Minute Disposable Application PadDORSAVI LTD30Min-DAP2019-09-26
B7580000PS100Professional SuiteDORSAVI LTD0000PS1002019-09-26
B7580000VMV50Movement Suite / V5 Sensor KitDORSAVI LTD0000VMV502019-09-26
B758000RDA482dorsaViDORSAVI LTDV6 Sensor Adhesive2020-08-04
07540191000586MyOnyx Mobile AppTechnologie de Pensée LtéeSA90302023-06-07
07540191000593MyOnyx Technologie de Pensée LtéeSA90202023-06-07
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
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
08592566001192Set for the application of EEG recording gelDEYMED Diagnostic s.r.o. 2023-06-12
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 connection DEYMED 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