Device, Biofeedback
Regulation 882.5050
0510(k)s in 12 months (172 all time)
0recalls in 12 months (4 all time)
2recalls that name a 510(k)
Top companies in HCC
| Company | 510(k)s | Recalls |
|---|---|---|
| Thought Technology , Ltd. | 14 | 0 |
| Bio-Feedback Systems, Inc. | 9 | 0 |
| Moe | 6 | 0 |
| Calnor of EL Paseo, Inc. | 5 | 0 |
| Fasstech | 5 | 0 |
| Verimed Holdings, Inc. | 5 | 0 |
| The Prometheus Group | 4 | 0 |
| Stoelting Co. | 4 | 0 |
| Atlas Researches , Ltd. | 3 | 0 |
| Autoject Systems, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 2024 | K233580 | A Breathing System (ABS) Deepwell Dtx, Inc. | HCC |
| Mar 17, 2023 | K222101 | Prism Graymatters Health , Ltd., IL | HCC |
| Aug 23, 2018 | K180173 | Freespira Palo Alto Health Sciences, Inc. | HCC |
| Sep 1, 2017 | K163448 | GrindCare System Sunstar Suisse S.A., CH | HCC |
| Dec 22, 2015 | K151050 | Pacifier Activated Lullaby (PAL®) Power Medical Devices, LLC | HCC |
| Sep 9, 2015 | K143507 | NFANT Feeding Solution Nfant Labs, LLC | HCC |
| Dec 10, 2013 | K131586 | CANARY BREATHING SYSTEM Palo Alto Health Sciences, Inc. | HCC |
| Feb 6, 2013 | K122879 | EEGER4 MODEL 4.3 Eeg Software, LLC | HCC |
| Sep 29, 2011 | K111687 | EMG SYSTEM Myotronics-Noromed, Inc. | HCC |
| Mar 3, 2010 | K092675 | GRINDCARE Medotech A/S | HCC |
| Feb 28, 2008 | K073557 | EEG NEUROAMP, MODEL CS10137 Corscience GmbH & Co. KG, DE | HCC |
| Feb 1, 2008 | K071866 | NTRAINER SYSTEM Kcbiomedix, Inc. | HCC |
| Sep 5, 2007 | K071661 | ALPHAONE BIOFEEDBACK SYSTEM Telediagnostic Systems, Inc. | HCC |
| Aug 12, 2004 | K041244 | POLYGRAM NET BIOFEEDBACK APPLICATION Medtronic Vascular | HCC |
| Jul 2, 2002 | K020399 | RESPERATE; MODEL RR-150 Intercure , Ltd. | HCC |
| Dec 11, 2001 | K010388 | SONDREX P.A.L. SYSTEM Ohmeda Medical | HCC |
| Nov 13, 2001 | K013399 | MODEL MES-9000/EMG SYSTEM Myotronics-Noromed, Inc. | HCC |
| Oct 15, 2001 | K012384 | EAR MUFFINS Bio-Logic Systems Corp. | HCC |
| Oct 10, 2001 | K012011 | MODIFICATION TO A620 EEG Stoelting Co. | HCC |
| Sep 20, 2001 | K011964 | INSIGHT MILLENNIUM PLUS Fasstech | HCC |
| Sep 6, 2001 | K011823 | BIOREHAB SYSTEM Nicolet Biomedical, Inc. | HCC |
| Aug 30, 2001 | K011983 | INSIGHT GENESIS Fasstech | HCC |
| Jan 4, 2001 | K003367 | ORION PLATINUM Srs Medical Systems, Inc. | HCC |
| Jan 4, 2001 | K003127 | REGAIN DESKTOP Srs Medical Systems, Inc. | HCC |
| May 17, 2000 | K000405 | INTERCURE LTD. RESPI-LOW Intercure , Ltd. | HCC |
| Jan 27, 2000 | K993654 | NEUROCOMP Neurocybernetics | HCC |
| Aug 13, 1999 | K992439 | NORODYN 8000 SEMG SYSTEM, ND-8000 Myotronics-Noromed, Inc. | HCC |
| Jun 3, 1999 | K990778 | INSIGHT MILLENNIUM Fasstech | HCC |
| May 19, 1999 | K990538 | BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE Brainmaster | HCC |
| Apr 29, 1999 | K990356 | THE BAGNOLI-8 EMG SYSTEM Delsys, Inc. | HCC |
| Jan 7, 1999 | K983550 | XYZ SYSTEM Bio-Monitoring International Corp. | HCC |
| Aug 31, 1998 | K981934 | THE BAGNOLI-4 EMG SYSTEM Delsys, Inc. | HCC |
| Aug 7, 1998 | K981844 | SLEEP MANAGEMENT SYSTEM Rmp, Inc. | HCC |
| Apr 29, 1998 | K980373 | ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE Ultramind International , Ltd., IL | HCC |
| Apr 14, 1998 | K971400 | MUSCLE RESPONSE MONITOR Enriching Your Life | HCC |
| Feb 18, 1998 | K971708 | PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE J & J Engineering, Inc. | HCC |
| Dec 17, 1997 | K973537 | PATHWAY ELECTROMYOGRAPH The Prometheus Group | HCC |
| Oct 2, 1997 | K972723 | BIO TROL Mindmedia Labs, Inc. | HCC |
| Sep 26, 1997 | K972487 | EMG RETRAINER Chattanooga Group, Inc. | HCC |
| Jul 10, 1997 | K970051 | MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE Smith and Nephew Donjoy, Inc. | HCC |
| Jun 25, 1997 | K943535 | MODEL ME 300 MUSCLE TESTER Regulatory Strategies, Inc. | HCC |
| May 19, 1997 | K963202 | MEGA ME 3000 PROFESSIONAL MUSCLE TESTER Mega Electronics , Ltd. | HCC |
| Feb 5, 1997 | K965006 | AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) Stoelting Co. | HCC |
| Oct 31, 1996 | K961645 | MRS-2D Lexicor Medical Technology, Inc. | HCC |
| Aug 27, 1996 | K961718 | DEI MODEL 20 EEG Discovery Engineering Intl., Inc. | HCC |
| Aug 7, 1996 | K960761 | PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 The Prometheus Group | HCC |
| Jul 3, 1996 | K954737 | SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE J-Tech, Inc. | HCC |
| Jun 13, 1996 | K960762 | SYNERGY PLUS The Prometheus Group | HCC |
| Apr 17, 1996 | K952797 | AT53 DUAL CHANNEL EMG Stoelting Co. | HCC |
| Mar 14, 1996 | K924313 | DIGITAL CONDUCTANCE METER The Jayms Co. | HCC |
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