FDA Product Code
FDA Product Code HCC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5050
510(k) Clearances — 172 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233580 | A Breathing System (ABS) | Deepwell Dtx, Inc. | 2024-08-01 | Traditional | PDF ↗ |
| K222101 | Prism | Graymatters Health , Ltd. | 2023-03-17 | Traditional | PDF ↗ |
| K180173 | Freespira | Palo Alto Health Sciences, Inc. | 2018-08-23 | Traditional | PDF ↗ |
| K163448 | GrindCare System | Sunstar Suisse S.A. | 2017-09-01 | Traditional | PDF ↗ |
| K151050 | Pacifier Activated Lullaby (PAL®) | Power Medical Devices, LLC | 2015-12-22 | Traditional | PDF ↗ |
| K143507 | NFANT Feeding Solution | Nfant Labs, LLC | 2015-09-09 | Traditional | PDF ↗ |
| K131586 | CANARY BREATHING SYSTEM | Palo Alto Health Sciences, Inc. | 2013-12-10 | Traditional | PDF ↗ |
| K122879 | EEGER4 MODEL 4.3 | Eeg Software, LLC | 2013-02-06 | Traditional | PDF ↗ |
| K111687 | EMG SYSTEM | Myotronics-Noromed, Inc. | 2011-09-29 | Special | PDF ↗ |
| K092675 | GRINDCARE | Medotech A/S | 2010-03-03 | Traditional | PDF ↗ |
| K073557 | EEG NEUROAMP, MODEL CS10137 | Corscience GmbH & Co. KG | 2008-02-28 | Traditional | PDF ↗ |
| K071866 | NTRAINER SYSTEM | Kcbiomedix, Inc. | 2008-02-01 | Traditional | PDF ↗ |
| K071661 | ALPHAONE BIOFEEDBACK SYSTEM | Telediagnostic Systems, Inc. | 2007-09-05 | Traditional | PDF ↗ |
| K041244 | POLYGRAM NET BIOFEEDBACK APPLICATION | Medtronic Vascular | 2004-08-12 | Traditional | PDF ↗ |
| K020399 | RESPERATE; MODEL RR-150 | Intercure , Ltd. | 2002-07-02 | Traditional | PDF ↗ |
| K010388 | SONDREX P.A.L. SYSTEM | Ohmeda Medical | 2001-12-11 | Traditional | PDF ↗ |
| K013399 | MODEL MES-9000/EMG SYSTEM | Myotronics-Noromed, Inc. | 2001-11-13 | Special | PDF ↗ |
| K012384 | EAR MUFFINS | Bio-Logic Systems Corp. | 2001-10-15 | Traditional | PDF ↗ |
| K012011 | MODIFICATION TO A620 EEG | Stoelting Co. | 2001-10-10 | Special | PDF ↗ |
| K011964 | INSIGHT MILLENNIUM PLUS | Fasstech | 2001-09-20 | Traditional | PDF ↗ |
| K011823 | BIOREHAB SYSTEM | Nicolet Biomedical, Inc. | 2001-09-06 | Abbreviated | PDF ↗ |
| K011983 | INSIGHT GENESIS | Fasstech | 2001-08-30 | Traditional | PDF ↗ |
| K003127 | REGAIN DESKTOP | Srs Medical Systems, Inc. | 2001-01-04 | Traditional | PDF ↗ |
| K003367 | ORION PLATINUM | Srs Medical Systems, Inc. | 2001-01-04 | Traditional | PDF ↗ |
| K000405 | INTERCURE LTD. RESPI-LOW | Intercure , Ltd. | 2000-05-17 | Traditional | PDF ↗ |
| K993654 | NEUROCOMP | Neurocybernetics | 2000-01-27 | Traditional | PDF ↗ |
| K992439 | NORODYN 8000 SEMG SYSTEM, ND-8000 | Myotronics-Noromed, Inc. | 1999-08-13 | Special | PDF ↗ |
| K990778 | INSIGHT MILLENNIUM | Fasstech | 1999-06-03 | Traditional | PDF ↗ |
| K990538 | BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE | Brainmaster | 1999-05-19 | Traditional | PDF ↗ |
| K990356 | THE BAGNOLI-8 EMG SYSTEM | Delsys, Inc. | 1999-04-29 | Traditional | PDF ↗ |
| K983550 | XYZ SYSTEM | Bio-Monitoring International Corp. | 1999-01-07 | Traditional | PDF ↗ |
| K981934 | THE BAGNOLI-4 EMG SYSTEM | Delsys, Inc. | 1998-08-31 | Traditional | PDF ↗ |
| K981844 | SLEEP MANAGEMENT SYSTEM | Rmp, Inc. | 1998-08-07 | Traditional | PDF ↗ |
| K980373 | ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE | Ultramind International , Ltd. | 1998-04-29 | Traditional | PDF ↗ |
| K971400 | MUSCLE RESPONSE MONITOR | Enriching Your Life | 1998-04-14 | Traditional | PDF ↗ |
| K971708 | PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE | J & J Engineering, Inc. | 1998-02-18 | Traditional | PDF ↗ |
| K973537 | PATHWAY ELECTROMYOGRAPH | The Prometheus Group | 1997-12-17 | Traditional | PDF ↗ |
| K972723 | BIO TROL | Mindmedia Labs, Inc. | 1997-10-02 | Traditional | PDF ↗ |
| K972487 | EMG RETRAINER | Chattanooga Group, Inc. | 1997-09-26 | Traditional | PDF ↗ |
| K970051 | MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE | Smith and Nephew Donjoy, Inc. | 1997-07-10 | Traditional | PDF ↗ |
| K943535 | MODEL ME 300 MUSCLE TESTER | Regulatory Strategies, Inc. | 1997-06-25 | Traditional | PDF ↗ |
| K963202 | MEGA ME 3000 PROFESSIONAL MUSCLE TESTER | Mega Electronics , Ltd. | 1997-05-19 | Traditional | PDF ↗ |
| K965006 | AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) | Stoelting Co. | 1997-02-05 | Traditional | PDF ↗ |
| K961645 | MRS-2D | Lexicor Medical Technology, Inc. | 1996-10-31 | Traditional | PDF ↗ |
| K961718 | DEI MODEL 20 EEG | Discovery Engineering Intl., Inc. | 1996-08-27 | Traditional | PDF ↗ |
| K960761 | PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 | The Prometheus Group | 1996-08-07 | Traditional | PDF ↗ |
| K954737 | SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE | J-Tech, Inc. | 1996-07-03 | Traditional | PDF ↗ |
| K960762 | SYNERGY PLUS | The Prometheus Group | 1996-06-13 | Traditional | PDF ↗ |
| K952797 | AT53 DUAL CHANNEL EMG | Stoelting Co. | 1996-04-17 | Traditional | PDF ↗ |
| K924313 | DIGITAL CONDUCTANCE METER | The Jayms Co. | 1996-03-14 | Traditional | PDF ↗ |
| K953257 | ORALSENSOR | Cycura Corp. | 1996-02-27 | Traditional | PDF ↗ |
| K954127 | BIOFEEDBACK DEVICE | Verimed Holdings, Inc. | 1995-11-14 | Traditional | PDF ↗ |
| K951213 | RELAXPLUS | Ultramind International , Ltd. | 1995-09-20 | Traditional | PDF ↗ |
| K944615 | A620 EEG | Stoelting Co. | 1995-09-18 | Traditional | PDF ↗ |
| K945286 | THE BAGNOLI-2 EMG SYSTEM | Delsys, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K942769 | BIOINTEGRATOR, BIOINTEGRATOR PLUS | Bio Research Institute | 1995-09-01 | Traditional | PDF ↗ |
| K945826 | J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS | Medical Device Inspection Co., Inc. | 1995-08-04 | Traditional | PDF ↗ |
| K951350 | MUSCLESENSE ELECTROMYOGRAPHY DEVICE | Smith and Nephew Donjoy, Inc. | 1995-06-23 | Traditional | PDF ↗ |
| K941959 | VERSATELL; VERSATELL-S | Progressive Concepts, Inc. | 1995-06-21 | Traditional | PDF ↗ |
| K951969 | MYOEXORCISER II FUAL | Verimed Holdings, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K930578 | AT33 EMG | Autoject Systems, Inc. | 1995-05-19 | Traditional | PDF ↗ |
| K930577 | AT64 SCR | Autoject Systems, Inc. | 1995-05-18 | Traditional | PDF ↗ |
| K930576 | AT42 | Autoject Systems, Inc. | 1995-05-18 | Traditional | PDF ↗ |
| K940050 | FOCUS EMG | Fasstech | 1995-02-24 | Traditional | PDF ↗ |
| K920038 | NEUROSEARCH-4 | Lexicor | 1995-02-08 | Traditional | PDF ↗ |
| K925750 | RELAXOMAT | Relaxomat, Inc. | 1995-01-31 | Traditional | PDF ↗ |
| K935853 | EMG TRAINER | Unitech | 1995-01-18 | Traditional | PDF ↗ |
| K922270 | PHYSIOTECH 4000 OR NORODYN 8000 | Myo-Tronics, Inc. | 1994-09-02 | Traditional | PDF ↗ |
| K941938 | THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE | Intercare Diagnostics, Inc. | 1994-08-05 | Traditional | PDF ↗ |
| K914925 | MEDAC SYSTEM/3 | Davicon, Inc. | 1993-10-21 | Traditional | PDF ↗ |
| K922838 | NORODYN 2000 ELECTROMYOGRAPH | Noromed, Inc. | 1993-09-22 | Traditional | PDF ↗ |
| K925197 | PSI 220 DUAL EMG | Fasstech | 1993-02-02 | Traditional | PDF ↗ |
| K914920 | BIOFEEDBACK SYSTEM/3 | Davicon, Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K915858 | MYOTRAC2 | Thought Technology , Ltd. | 1992-09-09 | Traditional | PDF ↗ |
| K915859 | MYOTRAC/S, MYODAC/S | Thought Technology , Ltd. | 1992-09-09 | Traditional | PDF ↗ |
| K913898 | MYOTRAC+/S, MYODAC+/S | Thought Technology , Ltd. | 1992-03-26 | Traditional | PDF ↗ |
| K911911 | MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM | Medical Design & Manufacturing Corp. | 1992-03-20 | Traditional | PDF ↗ |
| K912595 | AXIOM ELECTROMYOGRAPH | The Computerist, Inc. | 1991-09-06 | Traditional | PDF ↗ |
| K897132 | PATHWAY II ELECTROMYOGRAPH | The Prometheus Group | 1991-04-18 | Traditional | PDF ↗ |
| K905372 | MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002 | Bio-Feedback Systems, Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K905373 | MINIATURE TEMPERATURE TRAINER MODEL DT-002 | Bio-Feedback Systems, Inc. | 1991-04-10 | Traditional | PDF ↗ |
| K903497 | FLEXCOMP DSP & PROCOMP | Thought Technology , Ltd. | 1991-02-12 | Traditional | PDF ↗ |
| K902450 | BODYLOG ENHANCED STRESS REDUCTION PACKAGE | Bodylog, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K896409 | M(3):MICRO MUSCLE MONITOR | Thought Technology , Ltd. | 1990-10-09 | Traditional | PDF ↗ |
| K900639 | DYNATRON 350 EMG/BIOFEEDBACK ANALYZER | Dynatronics Laser Corp. | 1990-10-04 | Traditional | PDF ↗ |
| K895635 | MYOSYSTEM 1000 ELECTROMYOGRAPH | Noraxon USA, Inc. | 1990-04-19 | Traditional | PDF ↗ |
| K895633 | MYOTRACE 10 BIOFEEDBACK DEVICE | Noraxon USA, Inc. | 1990-04-13 | Traditional | PDF ↗ |
| K894510 | BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH | Capscan Corp. | 1990-01-16 | Traditional | PDF ↗ |
| K890500 | ELT OR ERGONOMIC LIFT TRAINER | Physical Health Devices, Inc. | 1990-01-03 | Traditional | PDF ↗ |
| K892649 | VERIMED MYOEXORCISER III (MYO III) | Verimed Holdings, Inc. | 1989-12-13 | Traditional | PDF ↗ |
| K892114 | ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM | Eclosion, Inc. | 1989-10-13 | Traditional | PDF ↗ |
| K894840 | MYODAC2 BIOFEEDBACK DEVICE | Thought Technology , Ltd. | 1989-10-13 | Traditional | PDF ↗ |
| K891693 | AUTOMATED THERAPY SYSTEM | Harding & Harris, Inc. | 1989-08-21 | Traditional | PDF ↗ |
| K881164 | LEUNOMED RFB 5000 | Hemodynamics, Inc. | 1989-04-24 | Traditional | PDF ↗ |
| K884849 | BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR | Moe | 1989-03-23 | Traditional | PDF ↗ |
| K884851 | BIOFEEDBACK DEVICE TG3, TG4 | Moe | 1989-02-03 | Traditional | PDF ↗ |
| K884848 | BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV | Moe | 1989-02-02 | Traditional | PDF ↗ |
| K884850 | BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30 | Moe | 1989-02-02 | Traditional | PDF ↗ |
| K884853 | BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1 | Moe | 1989-02-02 | Traditional | PDF ↗ |
| K884852 | BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI. | Moe | 1989-02-02 | Traditional | PDF ↗ |
Product code HCC · Class II · Neurology. Data: openFDA.