Product code HCC
- Device name
- Device, Biofeedback
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5050
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233580 | A Breathing System (ABS) | Deepwell Dtx, Inc. | 2024-08-01 |
| K222101 | Prism | Graymatters Health , Ltd. | 2023-03-17 |
| K180173 | Freespira | Palo Alto Health Sciences, Inc. | 2018-08-23 |
| K163448 | GrindCare System | Sunstar Suisse S.A. | 2017-09-01 |
| K151050 | Pacifier Activated Lullaby (PAL®) | Power Medical Devices, LLC | 2015-12-22 |
| K143507 | NFANT Feeding Solution | Nfant Labs, LLC | 2015-09-09 |
| K131586 | CANARY BREATHING SYSTEM | Palo Alto Health Sciences, Inc. | 2013-12-10 |
| K122879 | EEGER4 MODEL 4.3 | Eeg Software, LLC | 2013-02-06 |
| K111687 | EMG SYSTEM | Myotronics-Noromed, Inc. | 2011-09-29 |
| K092675 | GRINDCARE | Medotech A/S | 2010-03-03 |
| K073557 | EEG NEUROAMP, MODEL CS10137 | Corscience GmbH & Co. KG | 2008-02-28 |
| K071866 | NTRAINER SYSTEM | Kcbiomedix, Inc. | 2008-02-01 |
| K071661 | ALPHAONE BIOFEEDBACK SYSTEM | Telediagnostic Systems, Inc. | 2007-09-05 |
| K041244 | POLYGRAM NET BIOFEEDBACK APPLICATION | Medtronic Vascular | 2004-08-12 |
| K020399 | RESPERATE; MODEL RR-150 | Intercure , Ltd. | 2002-07-02 |
| K010388 | SONDREX P.A.L. SYSTEM | Ohmeda Medical | 2001-12-11 |
| K013399 | MODEL MES-9000/EMG SYSTEM | Myotronics-Noromed, Inc. | 2001-11-13 |
| K012384 | EAR MUFFINS | Bio-Logic Systems Corp. | 2001-10-15 |
| K012011 | MODIFICATION TO A620 EEG | Stoelting Co. | 2001-10-10 |
| K011964 | INSIGHT MILLENNIUM PLUS | Fasstech | 2001-09-20 |
| K011823 | BIOREHAB SYSTEM | Nicolet Biomedical, Inc. | 2001-09-06 |
| K011983 | INSIGHT GENESIS | Fasstech | 2001-08-30 |
| K003127 | REGAIN DESKTOP | Srs Medical Systems, Inc. | 2001-01-04 |
| K003367 | ORION PLATINUM | Srs Medical Systems, Inc. | 2001-01-04 |
| K000405 | INTERCURE LTD. RESPI-LOW | Intercure , Ltd. | 2000-05-17 |
| K993654 | NEUROCOMP | Neurocybernetics | 2000-01-27 |
| K992439 | NORODYN 8000 SEMG SYSTEM, ND-8000 | Myotronics-Noromed, Inc. | 1999-08-13 |
| K990778 | INSIGHT MILLENNIUM | Fasstech | 1999-06-03 |
| K990538 | BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE | Brainmaster | 1999-05-19 |
| K990356 | THE BAGNOLI-8 EMG SYSTEM | Delsys, Inc. | 1999-04-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08592566509506 | TruScan Neurofeedback Explorer | DEYMED Diagnostic s.r.o. | 2023-10-26 |
| 08592566639005 | Ear Electrode Sn (Tin) | DEYMED Diagnostic s.r.o. | 2023-10-26 |
| 08592566509001 | TruScan Neurofeedback Acquisition | DEYMED Diagnostic s.r.o. | 2023-10-26 |
| 08592566449000 | TruScan Neurofeedback optical cable V3.3L | DEYMED Diagnostic s.r.o. | 2023-10-26 |
| 08592566432392 | TruScan LT 32 Neurofeedback headbox | DEYMED Diagnostic s.r.o. | 2023-10-26 |
| 08592566431395 | TruScan LT 24 Neurofeedback headbox | DEYMED Diagnostic s.r.o. | 2023-10-26 |
| 08592566419003 | TruScan Neurofeedback Adapter | DEYMED Diagnostic s.r.o. | 2023-10-26 |
| 08592566001208 | Disposable blunted needles | DEYMED Diagnostic s.r.o. | 2023-10-26 |
| 08592566001161 | Disc Electrode 9mm Sn (Tin) | DEYMED Diagnostic s.r.o. | 2023-06-13 |
| 08592566001154 | Disc Electrode 9mm Sn (Tin) | DEYMED Diagnostic s.r.o. | 2023-06-13 |
| 08592566001147 | Disc Electrode 9mm Sn (Tin) | DEYMED Diagnostic s.r.o. | 2023-06-13 |
| 08592566629136 | FlexiCAP | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566629341 | Recording Cap G1 | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566629334 | Recording Cap G1 | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566629327 | Recording Cap G1 | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566629310 | Recording Cap G1 | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566629181 | Cable for connection | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566629174 | FlexiCAP | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566629167 | FlexiCAP | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566629150 | FlexiCAP | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566629143 | FlexiCAP | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566001192 | Set for the application of EEG recording gel | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566629129 | FlexiCAP | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566629112 | FlexiCAP | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566629105 | FlexiCAP | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566001093 | Pair of Ear Electrodes Sn (Tin) | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566001109 | Pair of Ear Electrodes Sn (Tin) | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566001116 | Pair of Ear Electrodes Sn (Tin) | DEYMED Diagnostic s.r.o. | 2023-06-12 |
| 08592566001024 | TruScan Neurofeedback 24ch | DEYMED Diagnostic s.r.o. | 2019-07-18 |
| 08592566001048 | TruScan Neurofeedback 32ch | DEYMED Diagnostic s.r.o. | 2019-07-18 |