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 2024-08-01

A Breathing System (ABS)

Applicant Deepwell Dtx, Inc.

K number K233580

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HCC 2023-03-17

Prism

Applicant Graymatters Health , Ltd.

K number K222101

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HCC 2018-08-23

Freespira

Applicant Palo Alto Health Sciences, Inc.

K number K180173

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HCC 2017-09-01

GrindCare System

Applicant Sunstar Suisse S.A.

K number K163448

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HCC 2013-12-10

CANARY BREATHING SYSTEM

Applicant Palo Alto Health Sciences, Inc.

K number K131586

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HCC 2013-02-06

EEGER4 MODEL 4.3

Applicant Eeg Software, LLC

K number K122879

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HCC 2011-09-29

EMG SYSTEM

Applicant Myotronics-Noromed, Inc.

K number K111687

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HCC 2010-03-03

GRINDCARE

Applicant Medotech A/S

K number K092675

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HCC 2008-02-28

EEG NEUROAMP, MODEL CS10137

Applicant Corscience GmbH & Co. KG

K number K073557

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HCC 2008-02-01

NTRAINER SYSTEM

Applicant Kcbiomedix, Inc.

K number K071866

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HCC 2007-09-05

ALPHAONE BIOFEEDBACK SYSTEM

Applicant Telediagnostic Systems, Inc.

K number K071661

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HCC 2004-08-12

POLYGRAM NET BIOFEEDBACK APPLICATION

Applicant Medtronic Vascular

K number K041244

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HCC 2002-07-02

RESPERATE; MODEL RR-150

Applicant Intercure , Ltd.

K number K020399

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HCC 2001-12-11

SONDREX P.A.L. SYSTEM

Applicant Ohmeda Medical

K number K010388

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HCC 2001-11-13

MODEL MES-9000/EMG SYSTEM

Applicant Myotronics-Noromed, Inc.

K number K013399

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HCC 2001-10-15

EAR MUFFINS

Applicant Bio-Logic Systems Corp.

K number K012384

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HCC 2001-10-10

MODIFICATION TO A620 EEG

Applicant Stoelting Co.

K number K012011

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HCC 2001-09-20

INSIGHT MILLENNIUM PLUS

Applicant Fasstech

K number K011964

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HCC 2001-09-06

BIOREHAB SYSTEM

Applicant Nicolet Biomedical, Inc.

K number K011823

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HCC 2001-08-30

INSIGHT GENESIS

Applicant Fasstech

K number K011983

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HCC 2001-01-04

ORION PLATINUM

Applicant Srs Medical Systems, Inc.

K number K003367

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HCC 2001-01-04

REGAIN DESKTOP

Applicant Srs Medical Systems, Inc.

K number K003127

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HCC 2000-05-17

INTERCURE LTD. RESPI-LOW

Applicant Intercure , Ltd.

K number K000405

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HCC 2000-01-27

NEUROCOMP

Applicant Neurocybernetics

K number K993654

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HCC 1999-08-13

NORODYN 8000 SEMG SYSTEM, ND-8000

Applicant Myotronics-Noromed, Inc.

K number K992439

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HCC 1999-06-03

INSIGHT MILLENNIUM

Applicant Fasstech

K number K990778

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HCC 1999-05-19

BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE

Applicant Brainmaster

K number K990538

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HCC 1999-04-29

THE BAGNOLI-8 EMG SYSTEM

Applicant Delsys, Inc.

K number K990356

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HCC 1999-01-07

XYZ SYSTEM

Applicant Bio-Monitoring International Corp.

K number K983550

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HCC 1998-08-31

THE BAGNOLI-4 EMG SYSTEM

Applicant Delsys, Inc.

K number K981934

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HCC 1998-08-07

SLEEP MANAGEMENT SYSTEM

Applicant Rmp, Inc.

K number K981844

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HCC 1998-04-29

ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE

Applicant Ultramind International , Ltd.

K number K980373

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HCC 1998-04-14

MUSCLE RESPONSE MONITOR

Applicant Enriching Your Life

K number K971400

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HCC 1998-02-18

PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE

Applicant J & J Engineering, Inc.

K number K971708

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HCC 1997-12-17

PATHWAY ELECTROMYOGRAPH

Applicant The Prometheus Group

K number K973537

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HCC 1997-10-02

BIO TROL

Applicant Mindmedia Labs, Inc.

K number K972723

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HCC 1997-09-26

EMG RETRAINER

Applicant Chattanooga Group, Inc.

K number K972487

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HCC 1997-07-10

MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE

Applicant Smith and Nephew Donjoy, Inc.

K number K970051

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HCC 1997-06-25

MODEL ME 300 MUSCLE TESTER

Applicant Regulatory Strategies, Inc.

K number K943535

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HCC 1997-05-19

MEGA ME 3000 PROFESSIONAL MUSCLE TESTER

Applicant Mega Electronics , Ltd.

K number K963202

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HCC 1997-02-05

AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER)

Applicant Stoelting Co.

K number K965006

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HCC 1996-10-31

MRS-2D

Applicant Lexicor Medical Technology, Inc.

K number K961645

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HCC 1996-08-27

DEI MODEL 20 EEG

Applicant Discovery Engineering Intl., Inc.

K number K961718

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HCC 1996-08-07

PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20

Applicant The Prometheus Group

K number K960761

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HCC 1996-07-03

SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE

Applicant J-Tech, Inc.

K number K954737

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HCC 1996-06-13

SYNERGY PLUS

Applicant The Prometheus Group

K number K960762

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HCC 1996-04-17

AT53 DUAL CHANNEL EMG

Applicant Stoelting Co.

K number K952797

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HCC 1996-03-14

DIGITAL CONDUCTANCE METER

Applicant The Jayms Co.

K number K924313

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HCC 1996-02-27

ORALSENSOR

Applicant Cycura Corp.

K number K953257

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HCC 1995-11-14

BIOFEEDBACK DEVICE

Applicant Verimed Holdings, Inc.

K number K954127

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HCC 1995-09-20

RELAXPLUS

Applicant Ultramind International , Ltd.

K number K951213

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HCC 1995-09-18

A620 EEG

Applicant Stoelting Co.

K number K944615

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HCC 1995-09-15

THE BAGNOLI-2 EMG SYSTEM

Applicant Delsys, Inc.

K number K945286

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HCC 1995-09-01

BIOINTEGRATOR, BIOINTEGRATOR PLUS

Applicant Bio Research Institute

K number K942769

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HCC 1995-08-04

J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS

Applicant Medical Device Inspection Co., Inc.

K number K945826

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HCC 1995-06-23

MUSCLESENSE ELECTROMYOGRAPHY DEVICE

Applicant Smith and Nephew Donjoy, Inc.

K number K951350

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HCC 1995-06-21

VERSATELL; VERSATELL-S

Applicant Progressive Concepts, Inc.

K number K941959

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HCC 1995-06-14

MYOEXORCISER II FUAL

Applicant Verimed Holdings, Inc.

K number K951969

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HCC 1995-05-19

AT33 EMG

Applicant Autoject Systems, Inc.

K number K930578

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HCC 1995-05-18

AT64 SCR

Applicant Autoject Systems, Inc.

K number K930577

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HCC 1995-05-18

AT42

Applicant Autoject Systems, Inc.

K number K930576

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HCC 1995-02-24

FOCUS EMG

Applicant Fasstech

K number K940050

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HCC 1995-02-08

NEUROSEARCH-4

Applicant Lexicor

K number K920038

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HCC 1995-01-31

RELAXOMAT

Applicant Relaxomat, Inc.

K number K925750

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HCC 1995-01-18

EMG TRAINER

Applicant Unitech

K number K935853

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HCC 1994-09-02

PHYSIOTECH 4000 OR NORODYN 8000

Applicant Myo-Tronics, Inc.

K number K922270

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HCC 1994-08-05

THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE

Applicant Intercare Diagnostics, Inc.

K number K941938

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HCC 1993-10-21

MEDAC SYSTEM/3

Applicant Davicon, Inc.

K number K914925

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HCC 1993-09-22

NORODYN 2000 ELECTROMYOGRAPH

Applicant Noromed, Inc.

K number K922838

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HCC 1993-02-02

PSI 220 DUAL EMG

Applicant Fasstech

K number K925197

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HCC 1992-11-16

BIOFEEDBACK SYSTEM/3

Applicant Davicon, Inc.

K number K914920

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HCC 1992-09-09

MYOTRAC/S, MYODAC/S

Applicant Thought Technology , Ltd.

K number K915859

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HCC 1992-09-09

MYOTRAC2

Applicant Thought Technology , Ltd.

K number K915858

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HCC 1992-03-26

MYOTRAC+/S, MYODAC+/S

Applicant Thought Technology , Ltd.

K number K913898

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HCC 1992-03-20

MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM

Applicant Medical Design & Manufacturing Corp.

K number K911911

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HCC 1991-09-06

AXIOM ELECTROMYOGRAPH

Applicant The Computerist, Inc.

K number K912595

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HCC 1991-04-18

PATHWAY II ELECTROMYOGRAPH

Applicant The Prometheus Group

K number K897132

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HCC 1991-04-12

MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002

Applicant Bio-Feedback Systems, Inc.

K number K905372

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HCC 1991-04-10

MINIATURE TEMPERATURE TRAINER MODEL DT-002

Applicant Bio-Feedback Systems, Inc.

K number K905373

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HCC 1991-02-12

FLEXCOMP DSP & PROCOMP

Applicant Thought Technology , Ltd.

K number K903497

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HCC 1991-01-25

BODYLOG ENHANCED STRESS REDUCTION PACKAGE

Applicant Bodylog, Inc.

K number K902450

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HCC 1990-10-09

M(3):MICRO MUSCLE MONITOR

Applicant Thought Technology , Ltd.

K number K896409

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HCC 1990-10-04

DYNATRON 350 EMG/BIOFEEDBACK ANALYZER

Applicant Dynatronics Laser Corp.

K number K900639

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HCC 1990-04-19

MYOSYSTEM 1000 ELECTROMYOGRAPH

Applicant Noraxon USA, Inc.

K number K895635

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HCC 1990-04-13

MYOTRACE 10 BIOFEEDBACK DEVICE

Applicant Noraxon USA, Inc.

K number K895633

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HCC 1990-01-16

BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH

Applicant Capscan Corp.

K number K894510

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HCC 1990-01-03

ELT OR ERGONOMIC LIFT TRAINER

Applicant Physical Health Devices, Inc.

K number K890500

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HCC 1989-12-13

VERIMED MYOEXORCISER III (MYO III)

Applicant Verimed Holdings, Inc.

K number K892649

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HCC 1989-10-13

MYODAC2 BIOFEEDBACK DEVICE

Applicant Thought Technology , Ltd.

K number K894840

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HCC 1989-10-13

ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM

Applicant Eclosion, Inc.

K number K892114

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HCC 1989-08-21

AUTOMATED THERAPY SYSTEM

Applicant Harding & Harris, Inc.

K number K891693

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HCC 1989-04-24

LEUNOMED RFB 5000

Applicant Hemodynamics, Inc.

K number K881164

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HCC 1989-03-23

BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR

Applicant Moe

K number K884849

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HCC 1989-02-03

BIOFEEDBACK DEVICE TG3, TG4

Applicant Moe

K number K884851

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HCC 1989-02-02

BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1

Applicant Moe

K number K884853

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HCC 1989-02-02

BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.

Applicant Moe

K number K884852

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HCC 1989-02-02

BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30

Applicant Moe

K number K884850

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HCC 1989-02-02

BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV

Applicant Moe

K number K884848

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HCC 1989-01-17

DM100 (DISTAL MONITOR - 100)

Applicant Bio.Logic, Inc.

K number K884135

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HCC 1988-11-16

MYODAC

Applicant Thought Technology , Ltd.

K number K883597

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