Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Device, Biofeedback

FDA product code HCC · 170 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5050
Review panel: NE
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-07-26 – 2024-08-01

HCC 1988-09-26

MYOTRAC

Applicant Thought Technology , Ltd.

K number K881416

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HCC 1988-08-15

DIGITAL EMG MONITOR MYOTRON 120

Applicant Ats Co.

K number K882266

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HCC 1988-06-17

MODEL BIOSTAR

Applicant Targus Concepts

K number K882062

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HCC 1988-05-11

M444 EMG MONITOR

Applicant Bio-Logic Devices

K number K880916

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HCC 1988-05-11

T824 TEMPERATURE MONITOR

Applicant Bio-Logic Devices

K number K880914

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HCC 1988-05-11

M424 EMG MONITOR

Applicant Bio-Logic Devices

K number K880913

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HCC 1988-03-24

INET MODEL BIOVISION

Applicant Inet Corp.

K number K873834

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HCC 1988-02-26

PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421

Applicant Self Regulation Systems, Inc.

K number K875308

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HCC 1987-12-17

BODYLOG STRESS REDUCTION PACKAGE

Applicant Bodylog, Inc.

K number K873418

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HCC 1987-08-04

BIOCOMP 2001 BIOFEEDBACK DEVICE

Applicant Biofeedback Research Institute, Inc.

K number K872495

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HCC 1987-08-04

BIO-PROMPT(TM)

Applicant Physical Health Devices, Inc.

K number K870568

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HCC 1987-05-01

SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE

Applicant Self Regulation Systems, Inc.

K number K870793

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HCC 1987-04-22

THE FM-212A BIOFEEDBACK UNIT

Applicant Hosa Technology, Inc.

K number K861950

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HCC 1986-06-18

BIOFEEDBACK MICROLAB

Applicant Hrm Software/Div. of Human Relations Media

K number K860271

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HCC 1986-01-21

NEUROPATH 4000

Applicant Therapeutic Technologies, Inc.

K number K854277

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HCC 1986-01-21

MYO-ACTUATOR

Applicant Verimed Holdings, Inc.

K number K852963

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HCC 1986-01-14

THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS

Applicant Bodylog, Inc.

K number K854208

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HCC 1985-12-10

MA-400 EMB FEEDBACK DEVICE

Applicant Spectral Data Systems

K number K853806

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HCC 1985-05-31

MYOMETER EMG BIOFEEDBACK DEVICE

Applicant Physio Technology, Inc.

K number K850849

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HCC 1985-05-23

COMPUTER INTERFACE - BIOFEEDBACK

Applicant M.O.E Electronics Research & Prod.

K number K850759

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HCC 1985-05-17

HR/BVP 100T HEART RATE MONITOR

Applicant Thought Technology , Ltd.

K number K850643

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HCC 1985-05-17

TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA

Applicant Thought Technology , Ltd.

K number K850642

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HCC 1984-12-04

CAB2 COMPUTER ASSISTED BIOFEEDBACK

Applicant Discrete Data Systems, Inc.

K number K843738

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HCC 1984-11-27

STRESS CONTROL BIOFEEDBACK CARD

Applicant Pilgrim Plastic Products Co.

K number K843413

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HCC 1984-07-20

TEMP. & GSR BIOFEEDBACK DEVICE

Applicant Electronics Research & Production

K number K842023

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HCC 1984-07-20

EEG BIOFEEDBACK DEVICE

Applicant Electronics Research & Production

K number K842022

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HCC 1984-07-20

EEG BIOFEEDBACK DEVICE ACCESSORY

Applicant Electronics Research & Production

K number K842021

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HCC 1984-07-17

EMG MODEL 133

Applicant Calnor of EL Paseo, Inc.

K number K842354

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HCC 1984-07-17

TEMPERATURE 132

Applicant Calnor of EL Paseo, Inc.

K number K842353

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HCC 1984-07-17

EEG 130

Applicant Calnor of EL Paseo, Inc.

K number K842288

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HCC 1984-07-17

GSR, 126, EEG 130-TEMP. 132, EMG 133

Applicant Calnor of EL Paseo, Inc.

K number K841895

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HCC 1984-07-16

RELAX STRESS REDUCTION SYS

Applicant Synapse Software Corp.

K number K841128

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HCC 1984-03-09

ORION BIOFEEDBACK DATA ACQUISITION

Applicant Self Regulation Systems, Inc.

K number K840223

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HCC 1984-02-04

ANTENSE ANTI-TENSION DEVICE

Applicant Bio Sig Instruments, Inc.

K number K834110

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HCC 1984-02-03

ANTACHE ANTI-HEADACHE DEVICE

Applicant Bio Sig Instruments, Inc.

K number K834111

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HCC 1984-01-30

CALMTONE

Applicant Thought Technology , Ltd.

K number K834519

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HCC 1983-10-28

VERIMED MYOEXORCISER

Applicant Verimed Holdings, Inc.

K number K832714

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HCC 1983-09-01

FEEDBACK EMG SYSTEM PE-020

Applicant Bio-Feedback Systems, Inc.

K number K832333

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HCC 1983-08-16

TA-400 TEMP. FEEDBACK DEVICE

Applicant Spectral Data Systems

K number K832146

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HCC 1983-08-12

ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED

Applicant Fluidotherapy Corp.

K number K832122

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HCC 1983-03-31

EMG BIOFEEDBACK DEVICE

Applicant Nemectron Medical, Inc.

K number K823511

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HCC 1983-03-24

BIOFEEDBACK-TRAINING INSTRUMENT

Applicant Relaxomat, Inc.

K number K830529

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HCC 1983-01-05

PROFESSIONAL MARK I BIOFEEDBACK SYS

Applicant Srs Co.

K number K823381

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HCC 1982-12-03

CALMSET 3 TM

Applicant Thought Technology , Ltd.

K number K823146

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HCC 1982-10-08

EMG 100T

Applicant Thought Technology , Ltd.

K number K822814

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HCC 1981-10-08

ISOLATED VOLTAGE/FREQUENCY CONVERTER

Applicant Bio-Feedback Systems, Inc.

K number K812619

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HCC 1981-08-25

LIFE-TECH #1753 BIOFEEDBACK TRAINER

Applicant Life-Tech Instruments, Inc.

K number K812179

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HCC 1981-05-27

ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A

Applicant Atlas Researches , Ltd.

K number K810882

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HCC 1981-05-27

EMG 3510/EMG 3510D MYOFEEDBACK MONITORS

Applicant Atlas Researches , Ltd.

K number K810881

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HCC 1981-05-27

AR-1 PHYSIOLOGICAL PRODESSOR

Applicant Atlas Researches , Ltd.

K number K810880

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HCC 1981-05-18

SC/TEMP 300

Applicant Thought Technology , Ltd.

K number K810332

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HCC 1981-03-02

BIOFEEDBACK BIO 80

Applicant Bimed, Inc.

K number K803099

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HCC 1981-01-09

EMG-UT 40

Applicant American Scientific Corp.

K number K802391

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HCC 1981-01-09

EMG-UT 30

Applicant American Scientific Corp.

K number K802390

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HCC 1980-06-26

V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU

Applicant Nebulae Productions

K number K801049

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HCC 1980-03-03

ALPHA DETECTOR

Applicant M.O.E Electronics Research & Prod.

K number K800319

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HCC 1980-03-03

BIOFEEDBACK DEVICES & ACCESSORIES

Applicant M.O.E Electronics Research & Prod.

K number K792115

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HCC 1980-01-09

FEEDBACK EDR SYSTEM MODEL ME-1

Applicant Bio-Feedback Systems, Inc.

K number K792659

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HCC 1979-08-28

APOLLO HEART RATE INDICATOR

Applicant Key Tronic Corp.

K number K791207

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HCC 1979-05-14

THE BIONIC EXERCISER

Applicant Scudder Molner Instruments

K number K790746

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HCC 1978-10-03

VISUALAX

Applicant Farrall Instruments, Inc.

K number K781634

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HCC 1978-05-12

RELAX-A-TONE

Applicant Bio Response

K number K780436

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HCC 1977-08-26

CLINICAL EMG MODEL 133

Applicant Calnor of EL Paseo, Inc.

K number K771577

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HCC 1977-06-24

ANALOG QUANTIFIER MODEL AQ-100

Applicant Bio-Feedback Systems, Inc.

K number K771023

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HCC 1977-06-17

RELAXATION COURSE MODEL 1000

Applicant Cybernetic Medical, Inc.

K number K770787

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HCC 1977-05-10

FEEDBACK EDR SYSTEM MODEL EDR-100

Applicant Bio-Feedback Systems, Inc.

K number K770790

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HCC 1977-04-26

FEEDBACK EMG SYSTEM, MODEL PE-L00

Applicant Bio-Feedback Systems, Inc.

K number K770663

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HCC 1977-03-15

MYOTRON

Applicant Somatronics, Inc.

K number K761350

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HCC 1977-02-24

TEMPERATURE FEEDBACK SYS, MODEL DT100

Applicant Bio-Feedback Systems, Inc.

K number K770270

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HCC 1976-07-26

MONITOR, GSR (NB-401)

Applicant Narco Bio-Systems

K number K760084

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