FDA 510(k) Applications for Medical Device Product Code "HCC"
(Device, Biofeedback)

FDA 510(k) Number Applicant Device Name Decision Date
K802390 AMERICAN SCIENTIFIC CORP. EMG-UT 30 01/09/1981
K802391 AMERICAN SCIENTIFIC CORP. EMG-UT 40 01/09/1981
K810880 ATLAS RESEARCHES LTD. AR-1 PHYSIOLOGICAL PRODESSOR 05/27/1981
K810882 ATLAS RESEARCHES LTD. ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A 05/27/1981
K810881 ATLAS RESEARCHES LTD. EMG 3510/EMG 3510D MYOFEEDBACK MONITORS 05/27/1981
K882266 ATS CO. DIGITAL EMG MONITOR MYOTRON 120 08/15/1988
K930578 AUTOJECT SYSTEMS, INC. AT33 EMG 05/19/1995
K930576 AUTOJECT SYSTEMS, INC. AT42 05/18/1995
K930577 AUTOJECT SYSTEMS, INC. AT64 SCR 05/18/1995
K803099 BIMED, INC. BIOFEEDBACK BIO 80 03/02/1981
K942769 BIO RESEARCH INSTITUTE BIOINTEGRATOR, BIOINTEGRATOR PLUS 09/01/1995
K780436 BIO RESPONSE "RELAX-A-TONE" 05/12/1978
K834111 BIO SIG INSTRUMENTS, INC. ANTACHE ANTI-HEADACHE DEVICE 02/03/1984
K834110 BIO SIG INSTRUMENTS, INC. ANTENSE ANTI-TENSION DEVICE 02/04/1984
K771023 BIO-FEEDBACK SYSTEMS, INC. ANALOG QUANTIFIER MODEL AQ-100 06/24/1977
K770790 BIO-FEEDBACK SYSTEMS, INC. FEEDBACK EDR SYSTEM MODEL EDR-100 05/10/1977
K792659 BIO-FEEDBACK SYSTEMS, INC. FEEDBACK EDR SYSTEM MODEL ME-1 01/09/1980
K832333 BIO-FEEDBACK SYSTEMS, INC. FEEDBACK EMG SYSTEM PE-020 09/01/1983
K770663 BIO-FEEDBACK SYSTEMS, INC. FEEDBACK EMG SYSTEM, MODEL PE-L00 04/26/1977
K812619 BIO-FEEDBACK SYSTEMS, INC. ISOLATED VOLTAGE/FREQUENCY CONVERTER 10/08/1981
K905372 BIO-FEEDBACK SYSTEMS, INC. MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002 04/12/1991
K905373 BIO-FEEDBACK SYSTEMS, INC. MINIATURE TEMPERATURE TRAINER MODEL DT-002 04/10/1991
K770270 BIO-FEEDBACK SYSTEMS, INC. TEMPERATURE FEEDBACK SYS, MODEL DT100 02/24/1977
K880913 BIO-LOGIC DEVICES M424 EMG MONITOR 05/11/1988
K880916 BIO-LOGIC DEVICES M444 EMG MONITOR 05/11/1988
K880914 BIO-LOGIC DEVICES T824 TEMPERATURE MONITOR 05/11/1988
K012384 BIO-LOGIC SYSTEMS CORP. EAR MUFFINS 10/15/2001
K983550 BIO-MONITORING INTERNATIONAL CORP. XYZ SYSTEM 01/07/1999
K884135 BIO.LOGIC, INC. DM100 (DISTAL MONITOR - 100) 01/17/1989
K872495 BIOFEEDBACK RESEARCH INSTITUTE, INC. BIOCOMP 2001 BIOFEEDBACK DEVICE 08/04/1987
K902450 BODYLOG, INC. "BODYLOG ENHANCED STRESS REDUCTION PACKAGE" 01/25/1991
K873418 BODYLOG, INC. BODYLOG STRESS REDUCTION PACKAGE 12/17/1987
K854208 BODYLOG, INC. THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS 01/14/1986
K990538 BRAINMASTER BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE 05/19/1999
K771577 CALNOR OF EL PASEO, INC. CLINICAL EMG MODEL 133 08/26/1977
K842288 CALNOR OF EL PASEO, INC. EEG 130 07/17/1984
K842354 CALNOR OF EL PASEO, INC. EMG MODEL 133 07/17/1984
K841895 CALNOR OF EL PASEO, INC. GSR, 126, EEG 130-TEMP. 132, EMG 133 07/17/1984
K842353 CALNOR OF EL PASEO, INC. TEMPERATURE 132 07/17/1984
K894510 CAPSCAN CORP. BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH 01/16/1990
K972487 CHATTANOOGA GROUP, INC. EMG RETRAINER 09/26/1997
K073557 CORSCIENCE GMBH & CO. KG EEG NEUROAMP, MODEL CS10137 02/28/2008
K770787 CYBERNETIC MEDICAL, INC. RELAXATION COURSE MOLEL 1000 06/17/1977
K953257 CYCURA CORP. ORALSENSOR 02/27/1996
K914920 DAVICON, INC. BIOFEEDBACK SYSTEM/3 11/16/1992
K914925 DAVICON, INC. MEDAC SYSTEM/3 10/21/1993
K945286 DELSYS, INC. THE BAGNOLI-2 EMG SYSTEM 09/15/1995
K981934 DELSYS, INC. THE BAGNOLI-4 EMG SYSTEM 08/31/1998
K990356 DELSYS, INC. THE BAGNOLI-8 EMG SYSTEM 04/29/1999
K961718 DISCOVERY ENGINEERING INTL., INC. DEI MODEL 20 EEG 08/27/1996
K843738 DISCRETE DATA SYSTEMS, INC. CAB2 COMPUTER ASSISTED BIOFEEDBACK 12/04/1984
K900639 DYNATRONICS LASER CORP. DYNATRON 350 EMG/BIOFEEDBACK ANALYZER 10/04/1990
K892114 ECLOSION, INC. ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM 10/13/1989
K122879 EEG SOFTWARE LLC EEGER4 MODEL 4.3 02/06/2013
K842022 ELECTRONICS RESEARCH & PRODUCTION EEG BIOFEEDBACK DEVICE 07/20/1984
K842021 ELECTRONICS RESEARCH & PRODUCTION EEG BIOFEEDBACK DEVICE ACCESSORY 07/20/1984
K842023 ELECTRONICS RESEARCH & PRODUCTION TEMP. & GSR BIOFEEDBACK DEVICE 07/20/1984
K971400 ENRICHING YOUR LIFE MUSCLE RESPONSE MONITOR 04/14/1998
K781634 FARRALL INSTRUMENTS, INC. VISUALAX 10/03/1978
K940050 FASSTECH FOCUS EMG 02/24/1995
K011983 FASSTECH INSIGHT GENESIS 08/30/2001
K990778 FASSTECH INSIGHT MILLENNIUM 06/03/1999
K011964 FASSTECH INSIGHT MILLENNIUM PLUS 09/20/2001
K925197 FASSTECH PSI 220 DUAL EMG 02/02/1993
K832122 FLUIDOTHERAPY CORP. ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED 08/12/1983
K891693 HARDING & HARRIS, INC. AUTOMATED THERAPY SYSTEM 08/21/1989
K881164 HEMODYNAMICS, INC. LEUNOMED RFB 5000 04/24/1989
K861950 HOSA TECHNOLOGY, INC. THE FM-212A BIOFEEDBACK UNIT 04/22/1987
K860271 HRM SOFTWARE/DIV. OF HUMAN RELATIONS MEDIA BIOFEEDBACK MICROLAB 06/18/1986
K873834 INET CORP. INET MODEL BIOVISION 03/24/1988
K941938 INTERCARE DIAGNOSTICS, INC. THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE 08/05/1994
K000405 INTERCURE LTD. INTERCURE LTD. RESPI-LOW 05/17/2000
K020399 INTERCURE LTD. RESPERATE; MODEL RR-150 07/02/2002
K971708 J & J ENGINEERING, INC. PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE 02/18/1998
K954737 J-TECH, INC. SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE 07/03/1996
K071866 KCBIOMEDIX, INC. NTRAINER SYSTEM 02/01/2008
K791207 KEY TRONIC CORP. APOLLO HEART RATE INDICATOR 08/28/1979
K920038 LEXICOR NEUROSEARCH-4 02/08/1995
K961645 LEXICOR MEDICAL TECHNOLOGY, INC. MRS-2D 10/31/1996
K812179 LIFE-TECH INSTRUMENTS, INC. LIFE-TECH #1753 BIOFEEDBACK TRAINER 08/25/1981
K800319 M.O.E ELECTRONICS RESEARCH & PROD. ALPHA DETECTOR 03/03/1980
K792115 M.O.E ELECTRONICS RESEARCH & PROD. BIOFEEDBACK DEVICES & ACCESSORIES 03/03/1980
K850759 M.O.E ELECTRONICS RESEARCH & PROD. COMPUTER INTERFACE - BIOFEEDBACK 05/23/1985
K911911 MEDICAL DESIGN & MANUFACTURING CORP. MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM 03/20/1992
K945826 MEDICAL DEVICE INSPECTION CO., INC. J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS 08/04/1995
K092675 MEDOTECH A/S GRINDCARE 03/03/2010
K041244 MEDTRONIC VASCULAR POLYGRAM NET BIOFEEDBACK APPLICATION 08/12/2004
K963202 MEGA ELECTRONICS LTD. MEGA ME 3000 PROFESSIONAL MUSCLE TESTER 05/19/1997
K972723 MINDMEDIA LABS, INC. BIO TROL 10/02/1997
K884848 MOE BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV 02/02/1989
K884849 MOE BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR 03/23/1989
K884852 MOE BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI. 02/02/1989
K884851 MOE BIOFEEDBACK DEVICE TG3, TG4 02/03/1989
K884853 MOE BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1 02/02/1989
K884850 MOE BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30 02/02/1989
K922270 MYO-TRONICS, INC. PHYSIOTECH 4000 OR NORODYN 8000 09/02/1994
K111687 MYOTRONICS-NOROMED, INC. EMG SYSTEM 09/29/2011
K013399 MYOTRONICS-NOROMED, INC. MODEL MES-9000/EMG SYSTEM 11/13/2001
K992439 MYOTRONICS-NOROMED, INC. NORODYN 8000 SEMG SYSTEM, ND-8000 08/13/1999
K760084 NARCO BIO-SYSTEMS MONITOR, GSR (NB-401) 07/26/1976
K801049 NEBULAE PRODUCTIONS V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU 06/26/1980
K823511 NEMECTRON MEDICAL, INC. EMG BIOFEEDBACK DEVICE 03/31/1983
K993654 NEUROCYBERNETICS NEUROCOMP 01/27/2000
K143507 NFANT Labs, LLC NFANT Feeding Solution 09/09/2015
K011823 NICOLET BIOMEDICAL, INC. BIOREHAB SYSTEM 09/06/2001
K895635 NORAXON USA, INC. MYOSYSTEM 1000 "ELECTROMYOGRAPH" 04/19/1990
K895633 NORAXON USA, INC. MYOTRACE 10 "BIOFEEDBACK DEVICE" 04/13/1990
K922838 NOROMED, INC. NORODYN 2000 ELECTROMYOGRAPH 09/22/1993
K010388 OHMEDA MEDICAL SONDREX P.A.L. SYSTEM 12/11/2001
K131586 PALO ALTO HEALTH SCIENCES, INC. CANCARY BREATHING SYSTEM 12/10/2013
K180173 Palo Alto Health Sciences, Inc. Freespira 08/23/2018
K870568 PHYSICAL HEALTH DEVICES, INC. BIO-PROMPT(TM) 08/04/1987
K890500 PHYSICAL HEALTH DEVICES, INC. ELT OR ERGONOMIC LIFT TRAINER 01/03/1990
K850849 PHYSIO TECHNOLOGY, INC. MYOMETER EMG BIOFEEDBACK DEVICE 05/31/1985
K843413 PILGRIM PLASTIC PRODUCTS CO. STRESS CONTROL BIOFEEDBACK CARD 11/27/1984
K151050 Power Medical Devices, LLC Pacifier Activated Lullaby (PAL«) 12/22/2015
K941959 PROGRESSIVE CONCEPTS, INC. VERSATELL; VERSATELL-S 06/21/1995
K943535 REGULATORY STRATEGIES, INC. MODEL ME 300 MUSCLE TESTER 06/25/1997
K830529 RELAXOMAT, INC. BIOFEEDBACK-TRAINING INSTRUMENT 03/24/1983
K925750 RELAXOMAT, INC. RELAXOMAT 01/31/1995
K981844 RMP, INC. SLEEP MANAGEMENT SYSTEM 08/07/1998
K790746 SCUDDER MOLNER INSTRUMENTS THE "BIONIC EXERCISER" 05/14/1979
K840223 SELF REGULATION SYSTEMS, INC. ORION BIOFEEDBACK DATA ACQUISITION 03/09/1984
K875308 SELF REGULATION SYSTEMS, INC. PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421 02/26/1988
K870793 SELF REGULATION SYSTEMS, INC. SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE 05/01/1987
K951350 SMITH AND NEPHEW DONJOY, INC. MUSCLESENSE ELECTROMYOGRAPHY DEVICE 06/23/1995
K970051 SMITH AND NEPHEW DONJOY, INC. MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE 07/10/1997
K761350 SOMATRONICS, INC. MYOTRON 03/15/1977
K853806 SPECTRAL DATA SYSTEMS MA-400 EMB FEEDBACK DEVICE 12/10/1985
K832146 SPECTRAL DATA SYSTEMS TA-400 TEMP. FEEDBACK DEVICE 08/16/1983
K823381 SRS CO. PROFESSIONAL MARK I BIOFEEDBACK SYS 01/05/1983
K003367 SRS MEDICAL SYSTEMS, INC. ORION PLATINUM 01/04/2001
K003127 SRS MEDICAL SYSTEMS, INC. REGAIN DESKTOP 01/04/2001
K944615 STOELTING CO. A620 EEG 09/18/1995
K965006 STOELTING CO. AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) 02/05/1997
K952797 STOELTING CO. AT53 DUAL CHANNEL EMG 04/17/1996
K012011 STOELTING CO. MODIFICATION TO A620 EEG 10/10/2001
K163448 SUNSTAR SUISSE S.A. GrindCare System 09/01/2017
K841128 SYNAPSE SOFTWARE CORP. RELAX STRESS REDUCTION SYS 07/16/1984
K882062 TARGUS CONCEPTS MODEL BIOSTAR 06/17/1988
K071661 TELEDIAGNOSTIC SYSTEMS, INC. ALPHAONE BIOFEEDBACK SYSTEM 09/05/2007
K912595 THE COMPUTERIST, INC. AXIOM ELECTROMYOGRAPH 09/06/1991
K924313 THE JAYMS CO. DIGITAL CONDUCTANCE METER 03/14/1996
K973537 THE PROMETHEUS GROUP PATHWAY ELECTROMYOGRAPH 12/17/1997
K960761 THE PROMETHEUS GROUP PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 08/07/1996
K897132 THE PROMETHEUS GROUP PATHWAY II ELECTROMYOGRAPH 04/18/1991
K960762 THE PROMETHEUS GROUP SYNERGY PLUS 06/13/1996
K854277 THERAPEUTIC TECHNOLOGIES, INC. NEUROPATH 4000 01/21/1986
K823146 THOUGHT TECHNOLOGY LTD. CALMSET 3 TM 12/03/1982
K834519 THOUGHT TECHNOLOGY LTD. CALMTONE 01/30/1984
K822814 THOUGHT TECHNOLOGY LTD. EMG 100T 10/08/1982
K903497 THOUGHT TECHNOLOGY LTD. FLEXCOMP DSP & PROCOMP 02/12/1991
K850643 THOUGHT TECHNOLOGY LTD. HR/BVP 100T HEART RATE MONITOR 05/17/1985
K896409 THOUGHT TECHNOLOGY LTD. M(3):MICRO MUSCLE MONITOR 10/09/1990
K883597 THOUGHT TECHNOLOGY LTD. MYODAC 11/16/1988
K894840 THOUGHT TECHNOLOGY LTD. MYODAC2 BIOFEEDBACK DEVICE 10/13/1989
K881416 THOUGHT TECHNOLOGY LTD. MYOTRAC 09/26/1988
K913898 THOUGHT TECHNOLOGY LTD. MYOTRAC+/S, MYODAC+/S 03/26/1992
K915859 THOUGHT TECHNOLOGY LTD. MYOTRAC/S, MYODAC/S 09/09/1992
K915858 THOUGHT TECHNOLOGY LTD. MYOTRAC2 09/09/1992
K810332 THOUGHT TECHNOLOGY LTD. SC/TEMP 300 05/18/1981
K850642 THOUGHT TECHNOLOGY LTD. TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA 05/17/1985
K951213 ULTRAMIND INTERNATIONAL LTD. RELAXPLUS 09/20/1995
K980373 ULTRAMIND INTERNATIONAL LTD. ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE 04/29/1998
K935853 UNITECH EMG TRAINER 01/18/1995
K954127 VERIMED HOLDINGS, INC. BIOFEEDBACK DEVICE 11/14/1995
K852963 VERIMED HOLDINGS, INC. MYO-ACTUATOR 01/21/1986
K951969 VERIMED HOLDINGS, INC. MYOEXORCISER II FUAL 06/14/1995
K832714 VERIMED HOLDINGS, INC. VERIMED MYOEXORCISER 10/28/1983
K892649 VERIMED HOLDINGS, INC. VERIMED MYOEXORCISER III (MYO III) 12/13/1989


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