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 |
|---|---|---|---|
| 00816271020407 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271020377 | Noraxon | Noraxon U.S.A., Inc. | 2026-03-30 |
| 08719481550110 | NeXus 10 MK3 | Mind Media Europe B.V. | 2025-09-10 |
| 50885380198791 | Kangaroo | Cardinal Health 200, LLC | 2025-03-12 |
| 10853818007504 | USB C Adapter | PRECISION BIOMETRICS INC | 2024-09-03 |
| B758000VMPLU0 | ViMove+ | DORSAVI LTD | 2023-08-30 |
| B758000RDA891 | dorsaVi - V6 Low Back AMI DAP | DORSAVI LTD | 2023-08-30 |
| B758000RDA890 | dorsaVi - V6 EMG DAP | DORSAVI LTD | 2023-08-30 |
| B758000RDA483 | dorsaVi - V6 Overwrap Adhesives | DORSAVI LTD | 2023-08-30 |
| 00092237624456 | Richmar EMG Pro | Drive Devilbiss Healthcare | 2023-08-03 |
| 50885380195554 | NTRAINER | Cardinal Health 200, LLC | 2023-07-03 |
| 50885380195561 | NTRAINER | Cardinal Health 200, LLC | 2023-07-03 |
| 00092237623817 | TheraTouch UX2 | Drive Devilbiss Healthcare | 2022-09-07 |
| 08051122040919 | Shoulder Pacemaker device (wireless PC) | NCS LAB SRL | 2021-09-01 |
| 08051122040971 | Wireless app home mode - Kit | NCS LAB SRL | 2021-09-01 |
| 08051122040964 | Wireless app mode - Kit | NCS LAB SRL | 2021-09-01 |
| 08051122040957 | Wireless mode - Kit | NCS LAB SRL | 2021-09-01 |
| 08051122040940 | Stand-alone mode Kit | NCS LAB SRL | 2021-09-01 |
| 08051122040933 | MySPM@Home App | NCS LAB SRL | 2021-09-01 |
| 08051122040926 | MySPM App | NCS LAB SRL | 2021-09-01 |
| 08051122040902 | Shoulder Pacemaker device | NCS LAB SRL | 2021-09-01 |
| B179BAIO1 | baiobit | BTS SPA | 2020-12-14 |
| 00082161071051 | Intellinetix | BROWNMED, INC. | 2020-08-12 |
| B7580000PS100 | Professional Suite | DORSAVI LTD | 2019-09-26 |
| B7580000VMV50 | Movement Suite / V5 Sensor Kit | DORSAVI LTD | 2019-09-26 |
| 08055765540003 | FREMSLIFE | FREMSLIFE SRL | 2018-01-28 |
| B179TMJ | TMJOINT | BTS SPA | 2017-02-12 |
| 00190446163985 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| B179FE3 | FREEEMG | BTS SPA | 2016-07-06 |
| B179FR1 | FREEEMG | BTS SPA | 2016-07-06 |