Device, Biofeedback
FDA product code HCC · Class II (moderate risk) · 21 CFR 882.5050 · Neurology
172510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Thought Technology , Ltd. 14
- Bio-Feedback Systems, Inc. 9
- Moe 6
- Verimed Holdings, Inc. 5
- Calnor of EL Paseo, Inc. 5
- Fasstech 5
- The Prometheus Group 4
- Stoelting Co. 4
- Electronics Research & Production 3
- M.O.E Electronics Research & Prod. 3
- Myotronics-Noromed, Inc. 3
- Bodylog, Inc. 3
- Atlas Researches , Ltd. 3
- Self Regulation Systems, Inc. 3
- Autoject Systems, Inc. 3
- Delsys, Inc. 3
- Bio-Logic Devices 3
- Noraxon USA, Inc. 2
- American Scientific Corp. 2
- Davicon, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233580 | A Breathing System (ABS)HCC · Traditional | Deepwell Dtx, Inc. | 08/01/2024SE |
| K222101 | PrismHCC · Traditional | Graymatters Health , Ltd. | 03/17/2023SE |
| K180173 | FreespiraHCC · Traditional | Palo Alto Health Sciences, Inc. | 08/23/2018SE |
| K163448 | GrindCare SystemHCC · Traditional | Sunstar Suisse S.A. | 09/01/2017SE |
| K151050 | Pacifier Activated Lullaby (PAL®)HCC · Traditional | Power Medical Devices, LLC | 12/22/2015SE |
| K143507 | NFANT Feeding SolutionHCC · Traditional | Nfant Labs, LLC | 09/09/2015SE |
| K131586 | Canary Breathing SystemHCC · Traditional | Palo Alto Health Sciences, Inc. | 12/10/2013SE |
| K122879 | EEGER4 Model 4.3HCC · Traditional | Eeg Software, LLC | 02/06/2013SE |
| K111687 | Emg SystemHCC · Special | Myotronics-Noromed, Inc. | 09/29/2011SE |
| K092675 | GrindcareHCC · Traditional | Medotech A/S | 03/03/2010SE |
| K073557 | EEG Neuroamp, Model CS10137HCC · Traditional | Corscience GmbH & Co. KG | 02/28/2008SE |
| K071866 | Ntrainer SystemHCC · Traditional | Kcbiomedix, Inc. | 02/01/2008SE |
| K071661 | Alphaone Biofeedback SystemHCC · Traditional | Telediagnostic Systems, Inc. | 09/05/2007SE |
| K041244 | Polygram Net Biofeedback ApplicationHCC · Traditional | Medtronic Vascular | 08/12/2004SE |
| K020399 | Resperate; Model RR-150HCC · Traditional | Intercure , Ltd. | 07/02/2002SE |
| K010388 | Sondrex P.A.L. SystemHCC · Traditional | Ohmeda Medical | 12/11/2001SE |
| K013399 | Model MES-9000/EMG SystemHCC · Special | Myotronics-Noromed, Inc. | 11/13/2001SE |
| K012384 | Ear MuffinsHCC · Traditional | Bio-Logic Systems Corp. | 10/15/2001SE |
| K012011 | Modification to A620 EEGHCC · Special | Stoelting Co. | 10/10/2001SE |
| K011964 | Insight Millennium PlusHCC · Traditional | Fasstech | 09/20/2001SE |
| K011823 | Biorehab SystemHCC · Abbreviated | Nicolet Biomedical, Inc. | 09/06/2001SE |
| K011983 | Insight GenesisHCC · Traditional | Fasstech | 08/30/2001SE |
| K003367 | Orion PlatinumHCC · Traditional | Srs Medical Systems, Inc. | 01/04/2001SE |
| K003127 | Regain DesktopHCC · Traditional | Srs Medical Systems, Inc. | 01/04/2001SE |
| K000405 | Intercure Ltd. Respi-LowHCC · Traditional | Intercure , Ltd. | 05/17/2000SE |
| K993654 | NeurocompHCC · Traditional | Neurocybernetics | 01/27/2000SE |
| K992439 | Norodyn 8000 Semg System, ND-8000HCC · Special | Myotronics-Noromed, Inc. | 08/13/1999SE |
| K990778 | Insight MillenniumHCC · Traditional | Fasstech | 06/03/1999SE |
| K990538 | Brainmaster 2E Module and Software Biofeedback DeviceHCC · Traditional | Brainmaster | 05/19/1999SE |
| K990356 | The BAGNOLI-8 Emg SystemHCC · Traditional | Delsys, Inc. | 04/29/1999SE |
| K983550 | Xyz SystemHCC · Traditional | Bio-Monitoring International Corp. | 01/07/1999SE |
| K981934 | The BAGNOLI-4 Emg SystemHCC · Traditional | Delsys, Inc. | 08/31/1998SE |
| K981844 | Sleep Management SystemHCC · Traditional | Rmp, Inc. | 08/07/1998SE |
| K980373 | Ultramind Biofeedback System with De-Stress SoftwareHCC · Traditional | Ultramind International , Ltd. | 04/29/1998SE |
| K971400 | Muscle Response MonitorHCC · Traditional | Enriching Your Life | 04/14/1998SE |
| K971708 | Physiological Monitoring & Biofeedback Training DeviceHCC · Traditional | J & J Engineering, Inc. | 02/18/1998SE |
| K973537 | Pathway ElectromyographHCC · Traditional | The Prometheus Group | 12/17/1997SE |
| K972723 | Bio TrolHCC · Traditional | Mindmedia Labs, Inc. | 10/02/1997SE |
| K972487 | Emg RetrainerHCC · Traditional | Chattanooga Group, Inc. | 09/26/1997SE |
| K970051 | Musclesense II Clinical Electromyography DeviceHCC · Traditional | Smith and Nephew Donjoy, Inc. | 07/10/1997SE |
| K943535 | Model Me 300 Muscle TesterHCC · Traditional | Regulatory Strategies, Inc. | 06/25/1997SE |
| K963202 | Mega Me 3000 Professional Muscle TesterHCC · Traditional | Mega Electronics , Ltd. | 05/19/1997SE |
| K965006 | At 62 EEG (A.K.A the A;Pha-Theta Trainer)HCC · Traditional | Stoelting Co. | 02/05/1997SE |
| K961645 | MRS-2DHCC · Traditional | Lexicor Medical Technology, Inc. | 10/31/1996SE |
| K961718 | Dei Model 20 EEGHCC · Traditional | Discovery Engineering Intl., Inc. | 08/27/1996SE |
| K960761 | Pathway Electromyograph Model TR-10 & TR-20HCC · Traditional | The Prometheus Group | 08/07/1996SE |
| K954737 | Surface Electromyograph Biofeedback Muscle Activity DeviceHCC · Traditional | J-Tech, Inc. | 07/03/1996SE |
| K960762 | Synergy PlusHCC · Traditional | The Prometheus Group | 06/13/1996SE |
| K952797 | AT53 Dual Channel EmgHCC · Traditional | Stoelting Co. | 04/17/1996SE |
| K924313 | Digital Conductance MeterHCC · Traditional | The Jayms Co. | 03/14/1996SE |
| K953257 | OralsensorHCC · Traditional | Cycura Corp. | 02/27/1996SE |
| K954127 | Biofeedback DeviceHCC · Traditional | Verimed Holdings, Inc. | 11/14/1995SE |
| K951213 | RelaxplusHCC · Traditional | Ultramind International , Ltd. | 09/20/1995SE |
| K944615 | A620 EEGHCC · Traditional | Stoelting Co. | 09/18/1995SE |
| K945286 | The BAGNOLI-2 Emg SystemHCC · Traditional | Delsys, Inc. | 09/15/1995SE |
| K942769 | Biointegrator, Biointegrator PlusHCC · Traditional | Bio Research Institute | 09/01/1995SE |
| K945826 | J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software…HCC · Traditional | Medical Device Inspection Co., Inc. | 08/04/1995SE |
| K951350 | Musclesense Electromyography DeviceHCC · Traditional | Smith and Nephew Donjoy, Inc. | 06/23/1995SE |
| K941959 | Versatell; Versatell-SHCC · Traditional | Progressive Concepts, Inc. | 06/21/1995SE |
| K951969 | Myoexorciser II FualHCC · Traditional | Verimed Holdings, Inc. | 06/14/1995SE |
| K930578 | AT33 EmgHCC · Traditional | Autoject Systems, Inc. | 05/19/1995SE |
| K930577 | AT64 SCRHCC · Traditional | Autoject Systems, Inc. | 05/18/1995SE |
| K930576 | AT42HCC · Traditional | Autoject Systems, Inc. | 05/18/1995SE |
| K940050 | Focus EmgHCC · Traditional | Fasstech | 02/24/1995SE |
| K920038 | NEUROSEARCH-4HCC · Traditional | Lexicor | 02/08/1995SE |
| K925750 | RelaxomatHCC · Traditional | Relaxomat, Inc. | 01/31/1995SE |
| K935853 | Emg TrainerHCC · Traditional | Unitech | 01/18/1995SE |
| K922270 | Physiotech 4000 or Norodyn 8000HCC · Traditional | Myo-Tronics, Inc. | 09/02/1994SE |
| K941938 | The Mirage System Biofeedback InterfaceHCC · Traditional | Intercare Diagnostics, Inc. | 08/05/1994SE |
| K914925 | Medac SYSTEM/3HCC · Traditional | Davicon, Inc. | 10/21/1993SE |
| K922838 | Norodyn 2000 ElectromyographHCC · Traditional | Noromed, Inc. | 09/22/1993SE |
| K925197 | Psi 220 Dual EmgHCC · Traditional | Fasstech | 02/02/1993SE |
| K914920 | Biofeedback SYSTEM/3HCC · Traditional | Davicon, Inc. | 11/16/1992SE |
| K915859 | Myotrac/S, Myodac/SHCC · Traditional | Thought Technology , Ltd. | 09/09/1992SE |
| K915858 | MYOTRAC2HCC · Traditional | Thought Technology , Ltd. | 09/09/1992SE |
| K913898 | Myotrac+/S, Myodac+/SHCC · Traditional | Thought Technology , Ltd. | 03/26/1992SE |
| K911911 | Medical Designs, Inc. Bio-Therapy SystemHCC · Traditional | Medical Design & Manufacturing Corp. | 03/20/1992SE |
| K912595 | Axiom ElectromyographHCC · Traditional | The Computerist, Inc. | 09/06/1991SE |
| K897132 | Pathway II ElectromyographHCC · Traditional | The Prometheus Group | 04/18/1991SE |
| K905372 | Miniature Electrodermal Response Trainer EDR-002HCC · Traditional | Bio-Feedback Systems, Inc. | 04/12/1991SE |
| K905373 | Miniature Temperature Trainer Model DT-002HCC · Traditional | Bio-Feedback Systems, Inc. | 04/10/1991SE |
| K903497 | Flexcomp DSP & ProcompHCC · Traditional | Thought Technology , Ltd. | 02/12/1991SE |
| K902450 | Bodylog Enhanced Stress Reduction PackageHCC · Traditional | Bodylog, Inc. | 01/25/1991SE |
| K896409 | M(3):MICRO Muscle MonitorHCC · Traditional | Thought Technology , Ltd. | 10/09/1990SE |
| K900639 | Dynatron 350 Emg/Biofeedback AnalyzerHCC · Traditional | Dynatronics Laser Corp. | 10/04/1990SE |
| K895635 | Myosystem 1000 ElectromyographHCC · Traditional | Noraxon USA, Inc. | 04/19/1990SE |
| K895633 | Myotrace 10 Biofeedback DeviceHCC · Traditional | Noraxon USA, Inc. | 04/13/1990SE |
| K894510 | Biofeedback Electroencephalograph/ElectromyographHCC · Traditional | Capscan Corp. | 01/16/1990SE |
| K890500 | Elt or Ergonomic Lift TrainerHCC · Traditional | Physical Health Devices, Inc. | 01/03/1990SE |
| K892649 | Verimed Myoexorciser III (Myo III)HCC · Traditional | Verimed Holdings, Inc. | 12/13/1989SE |
| K894840 | MYODAC2 Biofeedback DeviceHCC · Traditional | Thought Technology , Ltd. | 10/13/1989SE |
| K892114 | Electro-Physio-Feedback-Xrroid* SystemHCC · Traditional | Eclosion, Inc. | 10/13/1989SE |
| K891693 | Automated Therapy SystemHCC · Traditional | Harding & Harris, Inc. | 08/21/1989SE |
| K881164 | Leunomed RFB 5000HCC · Traditional | Hemodynamics, Inc. | 04/24/1989SE |
| K884849 | Biofeedback Device Access. PI1,2,3,4,5/LIGHT BarHCC · Traditional | Moe | 03/23/1989SE |
| K884851 | Biofeedback Device TG3, TG4HCC · Traditional | Moe | 02/03/1989SE |
| K884853 | Biofeedback EEG1/2, EEG Ultra Low Noise, SYC1HCC · Traditional | Moe | 02/02/1989SE |
| K884852 | Biofeedback Device EMG1, Emg Ultra Low Noise Opti.HCC · Traditional | Moe | 02/02/1989SE |
| K884850 | Biofeedback TMG1, 4, BIO1, PA1, 2, BA1/BA30HCC · Traditional | Moe | 02/02/1989SE |
| K884848 | Basic BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, Ir ReceivHCC · Traditional | Moe | 02/02/1989SE |
| K884135 | DM100 (Distal Monitor - 100)HCC · Traditional | Bio.Logic, Inc. | 01/17/1989SE |
| K883597 | MyodacHCC · Traditional | Thought Technology , Ltd. | 11/16/1988SE |
| K881416 | MyotracHCC · Traditional | Thought Technology , Ltd. | 09/26/1988SE |
| K882266 | Digital Emg Monitor Myotron 120HCC · Traditional | Ats Co. | 08/15/1988SE |
| K882062 | Model BiostarHCC · Traditional | Targus Concepts | 06/17/1988SE |
| K880916 | M444 Emg MonitorHCC · Traditional | Bio-Logic Devices | 05/11/1988SE |
| K880914 | T824 Temperature MonitorHCC · Traditional | Bio-Logic Devices | 05/11/1988SE |
| K880913 | M424 Emg MonitorHCC · Traditional | Bio-Logic Devices | 05/11/1988SE |
| K873834 | Inet Model BiovisionHCC · Traditional | Inet Corp. | 03/24/1988SE |
| K875308 | Professional Series Biofeedback Devices Model 421HCC · Traditional | Self Regulation Systems, Inc. | 02/26/1988SE |
| K873418 | Bodylog Stress Reduction PackageHCC · Traditional | Bodylog, Inc. | 12/17/1987SE |
| K872495 | Biocomp 2001 Biofeedback DeviceHCC · Traditional | Biofeedback Research Institute, Inc. | 08/04/1987SE |
| K870568 | Bio-Prompt(Tm)HCC · Traditional | Physical Health Devices, Inc. | 08/04/1987SE |
| K870793 | Self Regulation Sys Prof Series Biofeedback DeviceHCC · Traditional | Self Regulation Systems, Inc. | 05/01/1987SE |
| K861950 | The FM-212A Biofeedback UnitHCC · Traditional | Hosa Technology, Inc. | 04/22/1987SE |
| K860271 | Biofeedback MicrolabHCC · Traditional | Hrm Software/Div. of Human Relations Media | 06/18/1986SE |
| K854277 | Neuropath 4000HCC · Traditional | Therapeutic Technologies, Inc. | 01/21/1986SE |
| K852963 | Myo-ActuatorHCC · Traditional | Verimed Holdings, Inc. | 01/21/1986SE |
| K854208 | The Bodylog 500 Ret Therapeutic ElectromyographicsHCC · Traditional | Bodylog, Inc. | 01/14/1986SE |
| K853806 | MA-400 Emb Feedback DeviceHCC · Traditional | Spectral Data Systems | 12/10/1985SE |
| K850849 | Myometer Emg Biofeedback DeviceHCC · Traditional | Physio Technology, Inc. | 05/31/1985SE |
| K850759 | Computer Interface - BiofeedbackHCC · Traditional | M.O.E Electronics Research & Prod. | 05/23/1985SE |
| K850643 | Hr/Bvp 100T Heart Rate MonitorHCC · Traditional | Thought Technology , Ltd. | 05/17/1985SE |
| K850642 | Temp/Sc 200T -Skin Conductance/Skin Temp BiofeedbaHCC · Traditional | Thought Technology , Ltd. | 05/17/1985SE |
| K843738 | CAB2 Computer Assisted BiofeedbackHCC · Traditional | Discrete Data Systems, Inc. | 12/04/1984SE |
| K843413 | Stress Control Biofeedback CardHCC · Traditional | Pilgrim Plastic Products Co. | 11/27/1984SE |
| K842023 | Temp. & GSR Biofeedback DeviceHCC · Traditional | Electronics Research & Production | 07/20/1984SE |
| K842022 | EEG Biofeedback DeviceHCC · Traditional | Electronics Research & Production | 07/20/1984SE |
| K842021 | EEG Biofeedback Device AccessoryHCC · Traditional | Electronics Research & Production | 07/20/1984SE |
| K842354 | Emg Model 133HCC · Traditional | Calnor of EL Paseo, Inc. | 07/17/1984SE |
| K842353 | Temperature 132HCC · Traditional | Calnor of EL Paseo, Inc. | 07/17/1984SE |
| K842288 | EEG 130HCC · Traditional | Calnor of EL Paseo, Inc. | 07/17/1984SE |
| K841895 | GSR, 126, EEG 130-TEMP. 132, Emg 133HCC · Traditional | Calnor of EL Paseo, Inc. | 07/17/1984SE |
| K841128 | Relax Stress Reduction SysHCC · Traditional | Synapse Software Corp. | 07/16/1984SE |
| K840223 | Orion Biofeedback Data AcquisitionHCC · Traditional | Self Regulation Systems, Inc. | 03/09/1984SE |
| K834110 | Antense Anti-Tension DeviceHCC · Traditional | Bio Sig Instruments, Inc. | 02/04/1984SE |
| K834111 | Antache Anti-Headache DeviceHCC · Traditional | Bio Sig Instruments, Inc. | 02/03/1984SE |
| K834519 | CalmtoneHCC · Traditional | Thought Technology , Ltd. | 01/30/1984SE |
| K832714 | Verimed MyoexorciserHCC · Traditional | Verimed Holdings, Inc. | 10/28/1983SE |
| K832333 | Feedback Emg System PE-020HCC · Traditional | Bio-Feedback Systems, Inc. | 09/01/1983SE |
| K832146 | TA-400 Temp. Feedback DeviceHCC · Traditional | Spectral Data Systems | 08/16/1983SE |
| K832122 | Enraf NONIVS2 Channel Emg/Temp. FeedHCC · Traditional | Fluidotherapy Corp. | 08/12/1983SE |
| K823511 | Emg Biofeedback DeviceHCC · Traditional | Nemectron Medical, Inc. | 03/31/1983SE |
| K830529 | Biofeedback-Training InstrumentHCC · Traditional | Relaxomat, Inc. | 03/24/1983SE |
| K823381 | Professional Mark I Biofeedback SysHCC · Traditional | Srs Co. | 01/05/1983SE |
| K823146 | Calmset 3 TMHCC · Traditional | Thought Technology , Ltd. | 12/03/1982SE |
| K822814 | Emg 100THCC · Traditional | Thought Technology , Ltd. | 10/08/1982SE |
| K812619 | Isolated Voltage/Frequency ConverterHCC · Traditional | Bio-Feedback Systems, Inc. | 10/08/1981SE |
| K812179 | Life-Tech #1753 Biofeedback TrainerHCC · Traditional | Life-Tech Instruments, Inc. | 08/25/1981SE |
| K810882 | ASR-3520 Skin Response MONITOR;ASR-3520AHCC · Traditional | Atlas Researches , Ltd. | 05/27/1981SE |
| K810881 | Emg 3510/EMG 3510D Myofeedback MonitorsHCC · Traditional | Atlas Researches , Ltd. | 05/27/1981SE |
| K810880 | AR-1 Physiological ProdessorHCC · Traditional | Atlas Researches , Ltd. | 05/27/1981SE |
| K810332 | Sc/Temp 300HCC · Traditional | Thought Technology , Ltd. | 05/18/1981SE |
| K803099 | Biofeedback Bio 80HCC · Traditional | Bimed, Inc. | 03/02/1981SE |
| K802391 | Emg-Ut 40HCC · Traditional | American Scientific Corp. | 01/09/1981SE |
| K802390 | Emg-Ut 30HCC · Traditional | American Scientific Corp. | 01/09/1981SE |
| K801049 | V.I.B.E. Video Interface Biofeedback EquHCC · Traditional | Nebulae Productions | 06/26/1980SE |
| K800319 | Alpha DetectorHCC · Traditional | M.O.E Electronics Research & Prod. | 03/03/1980SE |
| K792115 | Biofeedback Devices & AccessoriesHCC · Traditional | M.O.E Electronics Research & Prod. | 03/03/1980SE |
| K792659 | Feedback Edr System Model ME-1HCC · Traditional | Bio-Feedback Systems, Inc. | 01/09/1980SE |
| K791207 | Apollo Heart Rate IndicatorHCC · Traditional | Key Tronic Corp. | 08/28/1979SE |
| K790746 | The Bionic ExerciserHCC · Traditional | Scudder Molner Instruments | 05/14/1979SE |
| K781634 | VisualaxHCC · Traditional | Farrall Instruments, Inc. | 10/03/1978SE |
| K780436 | Relax-A-ToneHCC · Traditional | Bio Response | 05/12/1978SE |
| K771577 | Clinical Emg Model 133HCC · Traditional | Calnor of EL Paseo, Inc. | 08/26/1977SE |
| K771023 | Analog Quantifier Model AQ-100HCC · Traditional | Bio-Feedback Systems, Inc. | 06/24/1977SE |
| K770787 | Relaxation Course Model 1000HCC · Traditional | Cybernetic Medical, Inc. | 06/17/1977SE |
| K770790 | Feedback Edr System Model EDR-100HCC · Traditional | Bio-Feedback Systems, Inc. | 05/10/1977SE |
| K770663 | Feedback Emg System, Model PE-L00HCC · Traditional | Bio-Feedback Systems, Inc. | 04/26/1977SE |
| K761350 | MyotronHCC · Traditional | Somatronics, Inc. | 03/15/1977SE |
| K770270 | Temperature Feedback Sys, Model DT100HCC · Traditional | Bio-Feedback Systems, Inc. | 02/24/1977SE |
| K760084 | Monitor, GSR (NB-401)HCC · Traditional | Narco Bio-Systems | 07/26/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2737-2024 Class II | BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and…Neurofeedback systems removed due to missing design and development documentation and devices may not… | Ronan Medical LLC | 12/11/2023Open, Classified |
| Z-1782-2018 Class II | Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered…The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the… | Ondamed Inc | 07/07/2017Terminated |
| Z-0395-2016 Class II | The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the…PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not… | Powers Medical Devices, LLC | 10/01/2015Open, Classified |
| Z-0526-2013 Class II | EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and RelaxationEEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated… | EEG Info | 11/15/2012Terminated |