Atlas FDA

HCC

172 FDA 510(k) clearances · Product code

90 daysmedian time to decision
364 days90th percentile
172clearances measured

FDA profile

Official device name
Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Medical specialty
Neurology
Adverse events (MAUDE)
2002: 1 · 2003: 1 · 2004: 2 · 2005: 5 · 2006: 4 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
A Breathing System (ABS) (K233580)Deepwell Dtx, Inc.2024-08-01
Prism (K222101)Graymatters Health , Ltd.2023-03-17
Freespira (K180173)Palo Alto Health Sciences, Inc.2018-08-23
GrindCare System (K163448)Sunstar Suisse S.A.2017-09-01
Pacifier Activated Lullaby (PAL®) (K151050)Power Medical Devices, LLC2015-12-22
NFANT Feeding Solution (K143507)Nfant Labs, LLC2015-09-09
CANARY BREATHING SYSTEM (K131586)Palo Alto Health Sciences, Inc.2013-12-10
EEGER4 MODEL 4.3 (K122879)Eeg Software, LLC2013-02-06
EMG SYSTEM (K111687)Myotronics-Noromed, Inc.2011-09-29
GRINDCARE (K092675)Medotech A/S2010-03-03
EEG NEUROAMP, MODEL CS10137 (K073557)Corscience GmbH & Co. KG2008-02-28
NTRAINER SYSTEM (K071866)Kcbiomedix, Inc.2008-02-01
ALPHAONE BIOFEEDBACK SYSTEM (K071661)Telediagnostic Systems, Inc.2007-09-05
POLYGRAM NET BIOFEEDBACK APPLICATION (K041244)Medtronic Vascular2004-08-12
RESPERATE; MODEL RR-150 (K020399)Intercure , Ltd.2002-07-02
SONDREX P.A.L. SYSTEM (K010388)Ohmeda Medical2001-12-11
MODEL MES-9000/EMG SYSTEM (K013399)Myotronics-Noromed, Inc.2001-11-13
EAR MUFFINS (K012384)Bio-Logic Systems Corp.2001-10-15
MODIFICATION TO A620 EEG (K012011)Stoelting Co.2001-10-10
INSIGHT MILLENNIUM PLUS (K011964)Fasstech2001-09-20
BIOREHAB SYSTEM (K011823)Nicolet Biomedical, Inc.2001-09-06
INSIGHT GENESIS (K011983)Fasstech2001-08-30
ORION PLATINUM (K003367)Srs Medical Systems, Inc.2001-01-04
REGAIN DESKTOP (K003127)Srs Medical Systems, Inc.2001-01-04
INTERCURE LTD. RESPI-LOW (K000405)Intercure , Ltd.2000-05-17
NEUROCOMP (K993654)Neurocybernetics2000-01-27
NORODYN 8000 SEMG SYSTEM, ND-8000 (K992439)Myotronics-Noromed, Inc.1999-08-13
INSIGHT MILLENNIUM (K990778)Fasstech1999-06-03
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE (K990538)Brainmaster1999-05-19
THE BAGNOLI-8 EMG SYSTEM (K990356)Delsys, Inc.1999-04-29
XYZ SYSTEM (K983550)Bio-Monitoring International Corp.1999-01-07
THE BAGNOLI-4 EMG SYSTEM (K981934)Delsys, Inc.1998-08-31
SLEEP MANAGEMENT SYSTEM (K981844)Rmp, Inc.1998-08-07
ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE (K980373)Ultramind International , Ltd.1998-04-29
MUSCLE RESPONSE MONITOR (K971400)Enriching Your Life1998-04-14
PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE (K971708)J & J Engineering, Inc.1998-02-18
PATHWAY ELECTROMYOGRAPH (K973537)The Prometheus Group1997-12-17
BIO TROL (K972723)Mindmedia Labs, Inc.1997-10-02
EMG RETRAINER (K972487)Chattanooga Group, Inc.1997-09-26
MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE (K970051)Smith and Nephew Donjoy, Inc.1997-07-10
MODEL ME 300 MUSCLE TESTER (K943535)Regulatory Strategies, Inc.1997-06-25
MEGA ME 3000 PROFESSIONAL MUSCLE TESTER (K963202)Mega Electronics , Ltd.1997-05-19
AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) (K965006)Stoelting Co.1997-02-05
MRS-2D (K961645)Lexicor Medical Technology, Inc.1996-10-31
DEI MODEL 20 EEG (K961718)Discovery Engineering Intl., Inc.1996-08-27
PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 (K960761)The Prometheus Group1996-08-07
SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE (K954737)J-Tech, Inc.1996-07-03
SYNERGY PLUS (K960762)The Prometheus Group1996-06-13
AT53 DUAL CHANNEL EMG (K952797)Stoelting Co.1996-04-17
DIGITAL CONDUCTANCE METER (K924313)The Jayms Co.1996-03-14
ORALSENSOR (K953257)Cycura Corp.1996-02-27
BIOFEEDBACK DEVICE (K954127)Verimed Holdings, Inc.1995-11-14
RELAXPLUS (K951213)Ultramind International , Ltd.1995-09-20
A620 EEG (K944615)Stoelting Co.1995-09-18
THE BAGNOLI-2 EMG SYSTEM (K945286)Delsys, Inc.1995-09-15
BIOINTEGRATOR, BIOINTEGRATOR PLUS (K942769)Bio Research Institute1995-09-01
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS (K945826)Medical Device Inspection Co., Inc.1995-08-04
MUSCLESENSE ELECTROMYOGRAPHY DEVICE (K951350)Smith and Nephew Donjoy, Inc.1995-06-23
VERSATELL; VERSATELL-S (K941959)Progressive Concepts, Inc.1995-06-21
MYOEXORCISER II FUAL (K951969)Verimed Holdings, Inc.1995-06-14
AT33 EMG (K930578)Autoject Systems, Inc.1995-05-19
AT64 SCR (K930577)Autoject Systems, Inc.1995-05-18
AT42 (K930576)Autoject Systems, Inc.1995-05-18
FOCUS EMG (K940050)Fasstech1995-02-24
NEUROSEARCH-4 (K920038)Lexicor1995-02-08
RELAXOMAT (K925750)Relaxomat, Inc.1995-01-31
EMG TRAINER (K935853)Unitech1995-01-18
PHYSIOTECH 4000 OR NORODYN 8000 (K922270)Myo-Tronics, Inc.1994-09-02
THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE (K941938)Intercare Diagnostics, Inc.1994-08-05
MEDAC SYSTEM/3 (K914925)Davicon, Inc.1993-10-21
NORODYN 2000 ELECTROMYOGRAPH (K922838)Noromed, Inc.1993-09-22
PSI 220 DUAL EMG (K925197)Fasstech1993-02-02
BIOFEEDBACK SYSTEM/3 (K914920)Davicon, Inc.1992-11-16
MYOTRAC/S, MYODAC/S (K915859)Thought Technology , Ltd.1992-09-09
MYOTRAC2 (K915858)Thought Technology , Ltd.1992-09-09
MYOTRAC+/S, MYODAC+/S (K913898)Thought Technology , Ltd.1992-03-26
MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM (K911911)Medical Design & Manufacturing Corp.1992-03-20
AXIOM ELECTROMYOGRAPH (K912595)The Computerist, Inc.1991-09-06
PATHWAY II ELECTROMYOGRAPH (K897132)The Prometheus Group1991-04-18
MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002 (K905372)Bio-Feedback Systems, Inc.1991-04-12
MINIATURE TEMPERATURE TRAINER MODEL DT-002 (K905373)Bio-Feedback Systems, Inc.1991-04-10
FLEXCOMP DSP & PROCOMP (K903497)Thought Technology , Ltd.1991-02-12
BODYLOG ENHANCED STRESS REDUCTION PACKAGE (K902450)Bodylog, Inc.1991-01-25
M(3):MICRO MUSCLE MONITOR (K896409)Thought Technology , Ltd.1990-10-09
DYNATRON 350 EMG/BIOFEEDBACK ANALYZER (K900639)Dynatronics Laser Corp.1990-10-04
MYOSYSTEM 1000 ELECTROMYOGRAPH (K895635)Noraxon USA, Inc.1990-04-19
MYOTRACE 10 BIOFEEDBACK DEVICE (K895633)Noraxon USA, Inc.1990-04-13
BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH (K894510)Capscan Corp.1990-01-16
ELT OR ERGONOMIC LIFT TRAINER (K890500)Physical Health Devices, Inc.1990-01-03
VERIMED MYOEXORCISER III (MYO III) (K892649)Verimed Holdings, Inc.1989-12-13
ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM (K892114)Eclosion, Inc.1989-10-13
MYODAC2 BIOFEEDBACK DEVICE (K894840)Thought Technology , Ltd.1989-10-13
AUTOMATED THERAPY SYSTEM (K891693)Harding & Harris, Inc.1989-08-21
LEUNOMED RFB 5000 (K881164)Hemodynamics, Inc.1989-04-24
BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR (K884849)Moe1989-03-23
BIOFEEDBACK DEVICE TG3, TG4 (K884851)Moe1989-02-03
BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30 (K884850)Moe1989-02-02
BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV (K884848)Moe1989-02-02
BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1 (K884853)Moe1989-02-02
BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI. (K884852)Moe1989-02-02
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Every clearance here is in the API, with alerts when new ones post.