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/productcode/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](/device/K233580.md) | A Breathing System (ABS) | Deepwell Dtx, Inc. | Aug 1, 2024 | SESE |
| [K222101](/device/K222101.md) | Prism | Graymatters Health , Ltd. | Mar 17, 2023 | SESE |
| [K180173](/device/K180173.md) | Freespira | Palo Alto Health Sciences, Inc. | Aug 23, 2018 | SESE |
| [K163448](/device/K163448.md) | GrindCare System | Sunstar Suisse S.A. | Sep 1, 2017 | SESE |
| [K151050](/device/K151050.md) | Pacifier Activated Lullaby (PAL®) | Power Medical Devices, LLC | Dec 22, 2015 | SESE |
| [K143507](/device/K143507.md) | NFANT Feeding Solution | Nfant Labs, LLC | Sep 9, 2015 | SESE |
| [K131586](/device/K131586.md) | CANARY BREATHING SYSTEM | Palo Alto Health Sciences, Inc. | Dec 10, 2013 | SESE |
| [K122879](/device/K122879.md) | EEGER4 MODEL 4.3 | Eeg Software, LLC | Feb 6, 2013 | SESE |
| [K111687](/device/K111687.md) | EMG SYSTEM | Myotronics-Noromed, Inc. | Sep 29, 2011 | SESE |
| [K092675](/device/K092675.md) | GRINDCARE | Medotech A/S | Mar 3, 2010 | SESE |
| [K073557](/device/K073557.md) | EEG NEUROAMP, MODEL CS10137 | Corscience GmbH & Co. KG | Feb 28, 2008 | SESE |
| [K071866](/device/K071866.md) | NTRAINER SYSTEM | Kcbiomedix, Inc. | Feb 1, 2008 | SESE |
| [K071661](/device/K071661.md) | ALPHAONE BIOFEEDBACK SYSTEM | Telediagnostic Systems, Inc. | Sep 5, 2007 | SESE |
| [K041244](/device/K041244.md) | POLYGRAM NET BIOFEEDBACK APPLICATION | Medtronic Vascular | Aug 12, 2004 | SESE |
| [K020399](/device/K020399.md) | RESPERATE; MODEL RR-150 | Intercure , Ltd. | Jul 2, 2002 | SESE |
| [K010388](/device/K010388.md) | SONDREX P.A.L. SYSTEM | Ohmeda Medical | Dec 11, 2001 | SESE |
| [K013399](/device/K013399.md) | MODEL MES-9000/EMG SYSTEM | Myotronics-Noromed, Inc. | Nov 13, 2001 | SESE |
| [K012384](/device/K012384.md) | EAR MUFFINS | Bio-Logic Systems Corp. | Oct 15, 2001 | SESE |
| [K012011](/device/K012011.md) | MODIFICATION TO A620 EEG | Stoelting Co. | Oct 10, 2001 | SESE |
| [K011964](/device/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

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**Source:** [https://fda.innolitics.com/productcode/HCC](https://fda.innolitics.com/productcode/HCC)

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