FDA 510(k) Applications for Medical Device Product Code "HCC"
(Device, Biofeedback)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K012384 | BIO-LOGIC SYSTEMS CORP. | EAR MUFFINS | 10/15/2001 |
| K983550 | BIO-MONITORING INTERNATIONAL CORP. | XYZ SYSTEM | 01/07/1999 |
| K990538 | BRAINMASTER | BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE | 05/19/1999 |
| K972487 | CHATTANOOGA GROUP, INC. | EMG RETRAINER | 09/26/1997 |
| K073557 | CORSCIENCE GMBH & CO. KG | EEG NEUROAMP, MODEL CS10137 | 02/28/2008 |
| K953257 | CYCURA CORP. | ORALSENSOR | 02/27/1996 |
| K981934 | DELSYS, INC. | THE BAGNOLI-4 EMG SYSTEM | 08/31/1998 |
| K990356 | DELSYS, INC. | THE BAGNOLI-8 EMG SYSTEM | 04/29/1999 |
| K961718 | DISCOVERY ENGINEERING INTL., INC. | DEI MODEL 20 EEG | 08/27/1996 |
| K122879 | EEG SOFTWARE LLC | EEGER4 MODEL 4.3 | 02/06/2013 |
| K971400 | ENRICHING YOUR LIFE | MUSCLE RESPONSE MONITOR | 04/14/1998 |
| K011983 | FASSTECH | INSIGHT GENESIS | 08/30/2001 |
| K990778 | FASSTECH | INSIGHT MILLENNIUM | 06/03/1999 |
| K011964 | FASSTECH | INSIGHT MILLENNIUM PLUS | 09/20/2001 |
| K222101 | GrayMatters Health Ltd. | Prism | 03/17/2023 |
| K000405 | INTERCURE LTD. | INTERCURE LTD. RESPI-LOW | 05/17/2000 |
| K020399 | INTERCURE LTD. | RESPERATE; MODEL RR-150 | 07/02/2002 |
| K971708 | J & J ENGINEERING, INC. | PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE | 02/18/1998 |
| K954737 | J-TECH, INC. | SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE | 07/03/1996 |
| K071866 | KCBIOMEDIX, INC. | NTRAINER SYSTEM | 02/01/2008 |
| K961645 | LEXICOR MEDICAL TECHNOLOGY, INC. | MRS-2D | 10/31/1996 |
| K092675 | MEDOTECH A/S | GRINDCARE | 03/03/2010 |
| K041244 | MEDTRONIC VASCULAR | POLYGRAM NET BIOFEEDBACK APPLICATION | 08/12/2004 |
| K963202 | MEGA ELECTRONICS LTD. | MEGA ME 3000 PROFESSIONAL MUSCLE TESTER | 05/19/1997 |
| K972723 | MINDMEDIA LABS, INC. | BIO TROL | 10/02/1997 |
| K111687 | MYOTRONICS-NOROMED, INC. | EMG SYSTEM | 09/29/2011 |
| K013399 | MYOTRONICS-NOROMED, INC. | MODEL MES-9000/EMG SYSTEM | 11/13/2001 |
| K992439 | MYOTRONICS-NOROMED, INC. | NORODYN 8000 SEMG SYSTEM, ND-8000 | 08/13/1999 |
| K993654 | NEUROCYBERNETICS | NEUROCOMP | 01/27/2000 |
| K143507 | NFANT Labs, LLC | NFANT Feeding Solution | 09/09/2015 |
| K011823 | NICOLET BIOMEDICAL, INC. | BIOREHAB SYSTEM | 09/06/2001 |
| K010388 | OHMEDA MEDICAL | SONDREX P.A.L. SYSTEM | 12/11/2001 |
| K131586 | PALO ALTO HEALTH SCIENCES, INC. | CANCARY BREATHING SYSTEM | 12/10/2013 |
| K180173 | Palo Alto Health Sciences, Inc. | Freespira | 08/23/2018 |
| K151050 | Power Medical Devices, LLC | Pacifier Activated Lullaby (PAL«) | 12/22/2015 |
| K943535 | REGULATORY STRATEGIES, INC. | MODEL ME 300 MUSCLE TESTER | 06/25/1997 |
| K981844 | RMP, INC. | SLEEP MANAGEMENT SYSTEM | 08/07/1998 |
| K970051 | SMITH AND NEPHEW DONJOY, INC. | MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE | 07/10/1997 |
| K003367 | SRS MEDICAL SYSTEMS, INC. | ORION PLATINUM | 01/04/2001 |
| K003127 | SRS MEDICAL SYSTEMS, INC. | REGAIN DESKTOP | 01/04/2001 |
| K965006 | STOELTING CO. | AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) | 02/05/1997 |
| K952797 | STOELTING CO. | AT53 DUAL CHANNEL EMG | 04/17/1996 |
| K012011 | STOELTING CO. | MODIFICATION TO A620 EEG | 10/10/2001 |
| K163448 | SUNSTAR SUISSE S.A. | GrindCare System | 09/01/2017 |
| K071661 | TELEDIAGNOSTIC SYSTEMS, INC. | ALPHAONE BIOFEEDBACK SYSTEM | 09/05/2007 |
| K924313 | THE JAYMS CO. | DIGITAL CONDUCTANCE METER | 03/14/1996 |
| K973537 | THE PROMETHEUS GROUP | PATHWAY ELECTROMYOGRAPH | 12/17/1997 |
| K960761 | THE PROMETHEUS GROUP | PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 | 08/07/1996 |
| K960762 | THE PROMETHEUS GROUP | SYNERGY PLUS | 06/13/1996 |
| K980373 | ULTRAMIND INTERNATIONAL LTD. | ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE | 04/29/1998 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
