Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5050](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5050) → HCC — Device, Biofeedback # HCC · Device, Biofeedback _Neurology · 21 CFR 882.5050 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC ## Overview - **Product Code:** HCC - **Device Name:** Device, Biofeedback - **Regulation:** [21 CFR 882.5050](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5050) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## Identification A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9. ## Recent Cleared Devices (20 of 172) Showing 20 most recent of 172 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K233580](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K233580.md) | A Breathing System (ABS) | Deepwell Dtx, Inc. | Aug 1, 2024 | SESE | | [K222101](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K222101.md) | Prism | Graymatters Health , Ltd. | Mar 17, 2023 | SESE | | [K180173](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K180173.md) | Freespira | Palo Alto Health Sciences, Inc. | Aug 23, 2018 | SESE | | [K163448](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K163448.md) | GrindCare System | Sunstar Suisse S.A. | Sep 1, 2017 | SESE | | [K151050](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K151050.md) | Pacifier Activated Lullaby (PAL®) | Power Medical Devices, LLC | Dec 22, 2015 | SESE | | [K143507](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K143507.md) | NFANT Feeding Solution | Nfant Labs, LLC | Sep 9, 2015 | SESE | | [K131586](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K131586.md) | CANARY BREATHING SYSTEM | Palo Alto Health Sciences, Inc. | Dec 10, 2013 | SESE | | [K122879](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K122879.md) | EEGER4 MODEL 4.3 | Eeg Software, LLC | Feb 6, 2013 | SESE | | [K111687](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K111687.md) | EMG SYSTEM | Myotronics-Noromed, Inc. | Sep 29, 2011 | SESE | | [K092675](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K092675.md) | GRINDCARE | Medotech A/S | Mar 3, 2010 | SESE | | [K073557](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K073557.md) | EEG NEUROAMP, MODEL CS10137 | Corscience GmbH & Co. KG | Feb 28, 2008 | SESE | | [K071866](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K071866.md) | NTRAINER SYSTEM | Kcbiomedix, Inc. | Feb 1, 2008 | SESE | | [K071661](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K071661.md) | ALPHAONE BIOFEEDBACK SYSTEM | Telediagnostic Systems, Inc. | Sep 5, 2007 | SESE | | [K041244](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K041244.md) | POLYGRAM NET BIOFEEDBACK APPLICATION | Medtronic Vascular | Aug 12, 2004 | SESE | | [K020399](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K020399.md) | RESPERATE; MODEL RR-150 | Intercure , Ltd. | Jul 2, 2002 | SESE | | [K010388](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K010388.md) | SONDREX P.A.L. SYSTEM | Ohmeda Medical | Dec 11, 2001 | SESE | | [K013399](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K013399.md) | MODEL MES-9000/EMG SYSTEM | Myotronics-Noromed, Inc. | Nov 13, 2001 | SESE | | [K012384](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K012384.md) | EAR MUFFINS | Bio-Logic Systems Corp. | Oct 15, 2001 | SESE | | [K012011](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K012011.md) | MODIFICATION TO A620 EEG | Stoelting Co. | Oct 10, 2001 | SESE | | [K011964](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K011964.md) | INSIGHT MILLENNIUM PLUS | Fasstech | Sep 20, 2001 | SESE | ## Top Applicants - Thought Technology , Ltd. — 14 clearances - Bio-Feedback Systems, Inc. — 9 clearances - Moe — 6 clearances - Calnor of EL Paseo, Inc. — 5 clearances - Fasstech — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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