Product Code: HCC FDA class 2 21 CFR 882.5050

Device, Biofeedback

Neurology

The Biofeedback Device is a neurological therapeutic instrument that measures physiological parameters such as muscle tension, skin conductance, heart rate, or brain wave activity and provides real-time feedback to patients to help them learn voluntary control over these functions for stress reduction, pain management, or rehabilitation. It is classified as a Class 2 device (moderate risk). The product code is HCC under regulation 21 CFR 882.5050 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.

View on FDA

510(k)s

172

FEI Numbers

101

Registration Numbers

101

Unique Applicants

Years Active

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Basic Information

Product Code: HCC
Device Class: FDA class 2
Regulation Number: 882.5050
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 172 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233580	A Breathing System (ABS)	Aug 01, 2024	Substantially Equivalent	Deepwell Dtx, Inc.
K222101	Prism	Mar 17, 2023	Substantially Equivalent	Graymatters Health , Ltd.
K180173	Freespira	Aug 23, 2018	Substantially Equivalent	Palo Alto Health Sciences, Inc.
K163448	GrindCare System	Sep 01, 2017	Substantially Equivalent	Sunstar Suisse S.A.
K151050	Pacifier Activated Lullaby (PAL®)	Dec 22, 2015	Substantially Equivalent	Power Medical Devices, LLC
K143507	NFANT Feeding Solution	Sep 09, 2015	Substantially Equivalent	Nfant Labs, LLC
K131586	CANARY BREATHING SYSTEM	Dec 10, 2013	Substantially Equivalent	Palo Alto Health Sciences, Inc.
K122879	EEGER4 MODEL 4.3	Feb 06, 2013	Substantially Equivalent	Eeg Software, LLC
K111687	EMG SYSTEM	Sep 29, 2011	Substantially Equivalent	Myotronics-Noromed, Inc.
K092675	GRINDCARE	Mar 03, 2010	Substantially Equivalent	Medotech A/S
K073557	EEG NEUROAMP, MODEL CS10137	Feb 28, 2008	Substantially Equivalent	Corscience GmbH & Co. KG
K071866	NTRAINER SYSTEM	Feb 01, 2008	Substantially Equivalent	Kcbiomedix, Inc.
K071661	ALPHAONE BIOFEEDBACK SYSTEM	Sep 05, 2007	Substantially Equivalent	Telediagnostic Systems, Inc.
K041244	POLYGRAM NET BIOFEEDBACK APPLICATION	Aug 12, 2004	Substantially Equivalent	Medtronic Vascular
K020399	RESPERATE; MODEL RR-150	Jul 02, 2002	Substantially Equivalent	Intercure , Ltd.
K010388	SONDREX P.A.L. SYSTEM	Dec 11, 2001	Substantially Equivalent	Ohmeda Medical
K013399	MODEL MES-9000/EMG SYSTEM	Nov 13, 2001	Substantially Equivalent	Myotronics-Noromed, Inc.
K012384	EAR MUFFINS	Oct 15, 2001	Substantially Equivalent	Bio-Logic Systems Corp.
K012011	MODIFICATION TO A620 EEG	Oct 10, 2001	Substantially Equivalent	Stoelting Co.
K011964	INSIGHT MILLENNIUM PLUS	Sep 20, 2001	Substantially Equivalent	Fasstech
K011823	BIOREHAB SYSTEM	Sep 06, 2001	Substantially Equivalent	Nicolet Biomedical, Inc.
K011983	INSIGHT GENESIS	Aug 30, 2001	Substantially Equivalent	Fasstech
K003367	ORION PLATINUM	Jan 04, 2001	Substantially Equivalent	Srs Medical Systems, Inc.
K003127	REGAIN DESKTOP	Jan 04, 2001	Substantially Equivalent	Srs Medical Systems, Inc.
K000405	INTERCURE LTD. RESPI-LOW	May 17, 2000	Substantially Equivalent	Intercure , Ltd.
K993654	NEUROCOMP	Jan 27, 2000	Substantially Equivalent	Neurocybernetics
K992439	NORODYN 8000 SEMG SYSTEM, ND-8000	Aug 13, 1999	Substantially Equivalent	Myotronics-Noromed, Inc.
K990778	INSIGHT MILLENNIUM	Jun 03, 1999	Substantially Equivalent	Fasstech
K990538	BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE	May 19, 1999	Substantially Equivalent	Brainmaster
K990356	THE BAGNOLI-8 EMG SYSTEM	Apr 29, 1999	Substantially Equivalent	Delsys, Inc.
K983550	XYZ SYSTEM	Jan 07, 1999	Substantially Equivalent	Bio-Monitoring International Corp.
K981934	THE BAGNOLI-4 EMG SYSTEM	Aug 31, 1998	Substantially Equivalent	Delsys, Inc.
K981844	SLEEP MANAGEMENT SYSTEM	Aug 07, 1998	Substantially Equivalent	Rmp, Inc.
K980373	ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE	Apr 29, 1998	Substantially Equivalent	Ultramind International , Ltd.
K971400	MUSCLE RESPONSE MONITOR	Apr 14, 1998	Substantially Equivalent	Enriching Your Life
K971708	PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE	Feb 18, 1998	Substantially Equivalent	J & J Engineering, Inc.
K973537	PATHWAY ELECTROMYOGRAPH	Dec 17, 1997	Substantially Equivalent	The Prometheus Group
K972723	BIO TROL	Oct 02, 1997	Substantially Equivalent	Mindmedia Labs, Inc.
K972487	EMG RETRAINER	Sep 26, 1997	Substantially Equivalent	Chattanooga Group, Inc.
K970051	MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE	Jul 10, 1997	Substantially Equivalent	Smith and Nephew Donjoy, Inc.
K943535	MODEL ME 300 MUSCLE TESTER	Jun 25, 1997	Substantially Equivalent	Regulatory Strategies, Inc.
K963202	MEGA ME 3000 PROFESSIONAL MUSCLE TESTER	May 19, 1997	Substantially Equivalent	Mega Electronics , Ltd.
K965006	AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER)	Feb 05, 1997	Substantially Equivalent	Stoelting Co.
K961645	MRS-2D	Oct 31, 1996	Substantially Equivalent	Lexicor Medical Technology, Inc.
K961718	DEI MODEL 20 EEG	Aug 27, 1996	Substantially Equivalent	Discovery Engineering Intl., Inc.
K960761	PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20	Aug 07, 1996	Substantially Equivalent	The Prometheus Group
K954737	SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE	Jul 03, 1996	Substantially Equivalent	J-Tech, Inc.
K960762	SYNERGY PLUS	Jun 13, 1996	Substantially Equivalent	The Prometheus Group
K952797	AT53 DUAL CHANNEL EMG	Apr 17, 1996	Substantially Equivalent	Stoelting Co.
K924313	DIGITAL CONDUCTANCE METER	Mar 14, 1996	Substantially Equivalent	The Jayms Co.
K953257	ORALSENSOR	Feb 27, 1996	Substantially Equivalent	Cycura Corp.
K954127	BIOFEEDBACK DEVICE	Nov 14, 1995	Substantially Equivalent	Verimed Holdings, Inc.
K951213	RELAXPLUS	Sep 20, 1995	Substantially Equivalent	Ultramind International , Ltd.
K944615	A620 EEG	Sep 18, 1995	Substantially Equivalent	Stoelting Co.
K945286	THE BAGNOLI-2 EMG SYSTEM	Sep 15, 1995	Substantially Equivalent	Delsys, Inc.
K942769	BIOINTEGRATOR, BIOINTEGRATOR PLUS	Sep 01, 1995	Substantially Equivalent	Bio Research Institute
K945826	J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS	Aug 04, 1995	Substantially Equivalent	Medical Device Inspection Co., Inc.
K951350	MUSCLESENSE ELECTROMYOGRAPHY DEVICE	Jun 23, 1995	Substantially Equivalent	Smith and Nephew Donjoy, Inc.
K941959	VERSATELL; VERSATELL-S	Jun 21, 1995	Substantially Equivalent	Progressive Concepts, Inc.
K951969	MYOEXORCISER II FUAL	Jun 14, 1995	Substantially Equivalent	Verimed Holdings, Inc.
K930578	AT33 EMG	May 19, 1995	Substantially Equivalent	Autoject Systems, Inc.
K930577	AT64 SCR	May 18, 1995	Substantially Equivalent	Autoject Systems, Inc.
K930576	AT42	May 18, 1995	Substantially Equivalent	Autoject Systems, Inc.
K940050	FOCUS EMG	Feb 24, 1995	Substantially Equivalent	Fasstech
K920038	NEUROSEARCH-4	Feb 08, 1995	Substantially Equivalent	Lexicor
K925750	RELAXOMAT	Jan 31, 1995	Substantially Equivalent	Relaxomat, Inc.
K935853	EMG TRAINER	Jan 18, 1995	Substantially Equivalent	Unitech
K922270	PHYSIOTECH 4000 OR NORODYN 8000	Sep 02, 1994	Substantially Equivalent	Myo-Tronics, Inc.
K941938	THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE	Aug 05, 1994	Substantially Equivalent	Intercare Diagnostics, Inc.
K914925	MEDAC SYSTEM/3	Oct 21, 1993	Substantially Equivalent	Davicon, Inc.
K922838	NORODYN 2000 ELECTROMYOGRAPH	Sep 22, 1993	Substantially Equivalent	Noromed, Inc.
K925197	PSI 220 DUAL EMG	Feb 02, 1993	Substantially Equivalent	Fasstech
K914920	BIOFEEDBACK SYSTEM/3	Nov 16, 1992	Substantially Equivalent	Davicon, Inc.
K915859	MYOTRAC/S, MYODAC/S	Sep 09, 1992	Substantially Equivalent	Thought Technology , Ltd.
K915858	MYOTRAC2	Sep 09, 1992	Substantially Equivalent	Thought Technology , Ltd.
K913898	MYOTRAC+/S, MYODAC+/S	Mar 26, 1992	Substantially Equivalent	Thought Technology , Ltd.
K911911	MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM	Mar 20, 1992	Substantially Equivalent	Medical Design & Manufacturing Corp.
K912595	AXIOM ELECTROMYOGRAPH	Sep 06, 1991	Substantially Equivalent	The Computerist, Inc.
K897132	PATHWAY II ELECTROMYOGRAPH	Apr 18, 1991	Substantially Equivalent	The Prometheus Group
K905372	MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002	Apr 12, 1991	Substantially Equivalent	Bio-Feedback Systems, Inc.
K905373	MINIATURE TEMPERATURE TRAINER MODEL DT-002	Apr 10, 1991	Substantially Equivalent	Bio-Feedback Systems, Inc.
K903497	FLEXCOMP DSP & PROCOMP	Feb 12, 1991	Substantially Equivalent	Thought Technology , Ltd.
K902450	BODYLOG ENHANCED STRESS REDUCTION PACKAGE	Jan 25, 1991	Substantially Equivalent	Bodylog, Inc.
K896409	M(3):MICRO MUSCLE MONITOR	Oct 09, 1990	Substantially Equivalent	Thought Technology , Ltd.
K900639	DYNATRON 350 EMG/BIOFEEDBACK ANALYZER	Oct 04, 1990	Substantially Equivalent	Dynatronics Laser Corp.
K895635	MYOSYSTEM 1000 ELECTROMYOGRAPH	Apr 19, 1990	Substantially Equivalent	Noraxon USA, Inc.
K895633	MYOTRACE 10 BIOFEEDBACK DEVICE	Apr 13, 1990	Substantially Equivalent	Noraxon USA, Inc.
K894510	BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH	Jan 16, 1990	Substantially Equivalent	Capscan Corp.
K890500	ELT OR ERGONOMIC LIFT TRAINER	Jan 03, 1990	Substantially Equivalent	Physical Health Devices, Inc.
K892649	VERIMED MYOEXORCISER III (MYO III)	Dec 13, 1989	Substantially Equivalent	Verimed Holdings, Inc.
K894840	MYODAC2 BIOFEEDBACK DEVICE	Oct 13, 1989	Substantially Equivalent	Thought Technology , Ltd.
K892114	ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM	Oct 13, 1989	Substantially Equivalent	Eclosion, Inc.
K891693	AUTOMATED THERAPY SYSTEM	Aug 21, 1989	Substantially Equivalent	Harding & Harris, Inc.
K881164	LEUNOMED RFB 5000	Apr 24, 1989	Substantially Equivalent	Hemodynamics, Inc.
K884849	BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR	Mar 23, 1989	Substantially Equivalent	Moe
K884851	BIOFEEDBACK DEVICE TG3, TG4	Feb 03, 1989	Substantially Equivalent	Moe
K884853	BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1	Feb 02, 1989	Substantially Equivalent	Moe
K884852	BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.	Feb 02, 1989	Substantially Equivalent	Moe
K884850	BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30	Feb 02, 1989	Substantially Equivalent	Moe
K884848	BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV	Feb 02, 1989	Substantially Equivalent	Moe
K884135	DM100 (DISTAL MONITOR - 100)	Jan 17, 1989	Substantially Equivalent	Bio.Logic, Inc.
K883597	MYODAC	Nov 16, 1988	Substantially Equivalent	Thought Technology , Ltd.
K881416	MYOTRAC	Sep 26, 1988	Substantially Equivalent	Thought Technology , Ltd.
K882266	DIGITAL EMG MONITOR MYOTRON 120	Aug 15, 1988	Substantially Equivalent	Ats Co.
K882062	MODEL BIOSTAR	Jun 17, 1988	Substantially Equivalent	Targus Concepts
K880916	M444 EMG MONITOR	May 11, 1988	Substantially Equivalent	Bio-Logic Devices
K880914	T824 TEMPERATURE MONITOR	May 11, 1988	Substantially Equivalent	Bio-Logic Devices
K880913	M424 EMG MONITOR	May 11, 1988	Substantially Equivalent	Bio-Logic Devices
K873834	INET MODEL BIOVISION	Mar 24, 1988	Substantially Equivalent	Inet Corp.
K875308	PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421	Feb 26, 1988	Substantially Equivalent	Self Regulation Systems, Inc.
K873418	BODYLOG STRESS REDUCTION PACKAGE	Dec 17, 1987	Substantially Equivalent	Bodylog, Inc.
K872495	BIOCOMP 2001 BIOFEEDBACK DEVICE	Aug 04, 1987	Substantially Equivalent	Biofeedback Research Institute, Inc.
K870568	BIO-PROMPT(TM)	Aug 04, 1987	Substantially Equivalent	Physical Health Devices, Inc.
K870793	SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE	May 01, 1987	Substantially Equivalent	Self Regulation Systems, Inc.
K861950	THE FM-212A BIOFEEDBACK UNIT	Apr 22, 1987	Substantially Equivalent	Hosa Technology, Inc.
K860271	BIOFEEDBACK MICROLAB	Jun 18, 1986	Substantially Equivalent	Hrm Software/Div. of Human Relations Media
K854277	NEUROPATH 4000	Jan 21, 1986	Substantially Equivalent	Therapeutic Technologies, Inc.
K852963	MYO-ACTUATOR	Jan 21, 1986	Substantially Equivalent	Verimed Holdings, Inc.
K854208	THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS	Jan 14, 1986	Substantially Equivalent	Bodylog, Inc.
K853806	MA-400 EMB FEEDBACK DEVICE	Dec 10, 1985	Substantially Equivalent	Spectral Data Systems
K850849	MYOMETER EMG BIOFEEDBACK DEVICE	May 31, 1985	Substantially Equivalent	Physio Technology, Inc.
K850759	COMPUTER INTERFACE - BIOFEEDBACK	May 23, 1985	Substantially Equivalent	M.O.E Electronics Research & Prod.
K850643	HR/BVP 100T HEART RATE MONITOR	May 17, 1985	Substantially Equivalent	Thought Technology , Ltd.
K850642	TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA	May 17, 1985	Substantially Equivalent	Thought Technology , Ltd.
K843738	CAB2 COMPUTER ASSISTED BIOFEEDBACK	Dec 04, 1984	Substantially Equivalent	Discrete Data Systems, Inc.
K843413	STRESS CONTROL BIOFEEDBACK CARD	Nov 27, 1984	Substantially Equivalent	Pilgrim Plastic Products Co.
K842023	TEMP. & GSR BIOFEEDBACK DEVICE	Jul 20, 1984	Substantially Equivalent	Electronics Research & Production
K842022	EEG BIOFEEDBACK DEVICE	Jul 20, 1984	Substantially Equivalent	Electronics Research & Production
K842021	EEG BIOFEEDBACK DEVICE ACCESSORY	Jul 20, 1984	Substantially Equivalent	Electronics Research & Production
K842354	EMG MODEL 133	Jul 17, 1984	Substantially Equivalent	Calnor of EL Paseo, Inc.
K842353	TEMPERATURE 132	Jul 17, 1984	Substantially Equivalent	Calnor of EL Paseo, Inc.
K842288	EEG 130	Jul 17, 1984	Substantially Equivalent	Calnor of EL Paseo, Inc.
K841895	GSR, 126, EEG 130-TEMP. 132, EMG 133	Jul 17, 1984	Substantially Equivalent	Calnor of EL Paseo, Inc.
K841128	RELAX STRESS REDUCTION SYS	Jul 16, 1984	Substantially Equivalent	Synapse Software Corp.
K840223	ORION BIOFEEDBACK DATA ACQUISITION	Mar 09, 1984	Substantially Equivalent	Self Regulation Systems, Inc.
K834110	ANTENSE ANTI-TENSION DEVICE	Feb 04, 1984	Substantially Equivalent	Bio Sig Instruments, Inc.
K834111	ANTACHE ANTI-HEADACHE DEVICE	Feb 03, 1984	Substantially Equivalent	Bio Sig Instruments, Inc.
K834519	CALMTONE	Jan 30, 1984	Substantially Equivalent	Thought Technology , Ltd.
K832714	VERIMED MYOEXORCISER	Oct 28, 1983	Substantially Equivalent	Verimed Holdings, Inc.
K832333	FEEDBACK EMG SYSTEM PE-020	Sep 01, 1983	Substantially Equivalent	Bio-Feedback Systems, Inc.
K832146	TA-400 TEMP. FEEDBACK DEVICE	Aug 16, 1983	Substantially Equivalent	Spectral Data Systems
K832122	ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED	Aug 12, 1983	Substantially Equivalent	Fluidotherapy Corp.
K823511	EMG BIOFEEDBACK DEVICE	Mar 31, 1983	Substantially Equivalent	Nemectron Medical, Inc.
K830529	BIOFEEDBACK-TRAINING INSTRUMENT	Mar 24, 1983	Substantially Equivalent	Relaxomat, Inc.
K823381	PROFESSIONAL MARK I BIOFEEDBACK SYS	Jan 05, 1983	Substantially Equivalent	Srs Co.
K823146	CALMSET 3 TM	Dec 03, 1982	Substantially Equivalent	Thought Technology , Ltd.
K822814	EMG 100T	Oct 08, 1982	Substantially Equivalent	Thought Technology , Ltd.
K812619	ISOLATED VOLTAGE/FREQUENCY CONVERTER	Oct 08, 1981	Substantially Equivalent	Bio-Feedback Systems, Inc.
K812179	LIFE-TECH #1753 BIOFEEDBACK TRAINER	Aug 25, 1981	Substantially Equivalent	Life-Tech Instruments, Inc.
K810882	ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A	May 27, 1981	Substantially Equivalent	Atlas Researches , Ltd.
K810881	EMG 3510/EMG 3510D MYOFEEDBACK MONITORS	May 27, 1981	Substantially Equivalent	Atlas Researches , Ltd.
K810880	AR-1 PHYSIOLOGICAL PRODESSOR	May 27, 1981	Substantially Equivalent	Atlas Researches , Ltd.
K810332	SC/TEMP 300	May 18, 1981	Substantially Equivalent	Thought Technology , Ltd.
K803099	BIOFEEDBACK BIO 80	Mar 02, 1981	Substantially Equivalent	Bimed, Inc.
K802391	EMG-UT 40	Jan 09, 1981	Substantially Equivalent	American Scientific Corp.
K802390	EMG-UT 30	Jan 09, 1981	Substantially Equivalent	American Scientific Corp.
K801049	V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU	Jun 26, 1980	Substantially Equivalent	Nebulae Productions
K800319	ALPHA DETECTOR	Mar 03, 1980	Substantially Equivalent	M.O.E Electronics Research & Prod.
K792115	BIOFEEDBACK DEVICES & ACCESSORIES	Mar 03, 1980	Substantially Equivalent	M.O.E Electronics Research & Prod.
K792659	FEEDBACK EDR SYSTEM MODEL ME-1	Jan 09, 1980	Substantially Equivalent	Bio-Feedback Systems, Inc.
K791207	APOLLO HEART RATE INDICATOR	Aug 28, 1979	Substantially Equivalent	Key Tronic Corp.
K790746	THE BIONIC EXERCISER	May 14, 1979	Substantially Equivalent	Scudder Molner Instruments
K781634	VISUALAX	Oct 03, 1978	Substantially Equivalent	Farrall Instruments, Inc.
K780436	RELAX-A-TONE	May 12, 1978	Substantially Equivalent	Bio Response
K771577	CLINICAL EMG MODEL 133	Aug 26, 1977	Substantially Equivalent	Calnor of EL Paseo, Inc.
K771023	ANALOG QUANTIFIER MODEL AQ-100	Jun 24, 1977	Substantially Equivalent	Bio-Feedback Systems, Inc.
K770787	RELAXATION COURSE MODEL 1000	Jun 17, 1977	Substantially Equivalent	Cybernetic Medical, Inc.
K770790	FEEDBACK EDR SYSTEM MODEL EDR-100	May 10, 1977	Substantially Equivalent	Bio-Feedback Systems, Inc.
K770663	FEEDBACK EMG SYSTEM, MODEL PE-L00	Apr 26, 1977	Substantially Equivalent	Bio-Feedback Systems, Inc.
K761350	MYOTRON	Mar 15, 1977	Substantially Equivalent	Somatronics, Inc.
K770270	TEMPERATURE FEEDBACK SYS, MODEL DT100	Feb 24, 1977	Substantially Equivalent	Bio-Feedback Systems, Inc.
K760084	MONITOR, GSR (NB-401)	Jul 26, 1976	Substantially Equivalent	Narco Bio-Systems