HCC · Device, Biofeedback
Neurology · 21 CFR 882.5050 · Class 2
Overview
| Product Code | HCC |
|---|---|
| Device Name | Device, Biofeedback |
| Regulation | 21 CFR 882.5050 |
| Device Class | Class 2 |
| Review Panel | Neurology |
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 | A Breathing System (ABS) | Deepwell Dtx, Inc. | Aug 1, 2024 | SESE |
| K222101 | Prism | Graymatters Health , Ltd. | Mar 17, 2023 | SESE |
| K180173 | Freespira | Palo Alto Health Sciences, Inc. | Aug 23, 2018 | SESE |
| K163448 | GrindCare System | Sunstar Suisse S.A. | Sep 1, 2017 | SESE |
| K151050 | Pacifier Activated Lullaby (PAL®) | Power Medical Devices, LLC | Dec 22, 2015 | SESE |
| K143507 | NFANT Feeding Solution | Nfant Labs, LLC | Sep 9, 2015 | SESE |
| K131586 | CANARY BREATHING SYSTEM | Palo Alto Health Sciences, Inc. | Dec 10, 2013 | SESE |
| K122879 | EEGER4 MODEL 4.3 | Eeg Software, LLC | Feb 6, 2013 | SESE |
| K111687 | EMG SYSTEM | Myotronics-Noromed, Inc. | Sep 29, 2011 | SESE |
| K092675 | GRINDCARE | Medotech A/S | Mar 3, 2010 | SESE |
| K073557 | EEG NEUROAMP, MODEL CS10137 | Corscience GmbH & Co. KG | Feb 28, 2008 | SESE |
| K071866 | NTRAINER SYSTEM | Kcbiomedix, Inc. | Feb 1, 2008 | SESE |
| K071661 | ALPHAONE BIOFEEDBACK SYSTEM | Telediagnostic Systems, Inc. | Sep 5, 2007 | SESE |
| K041244 | POLYGRAM NET BIOFEEDBACK APPLICATION | Medtronic Vascular | Aug 12, 2004 | SESE |
| K020399 | RESPERATE; MODEL RR-150 | Intercure , Ltd. | Jul 2, 2002 | SESE |
| K010388 | SONDREX P.A.L. SYSTEM | Ohmeda Medical | Dec 11, 2001 | SESE |
| K013399 | MODEL MES-9000/EMG SYSTEM | Myotronics-Noromed, Inc. | Nov 13, 2001 | SESE |
| K012384 | EAR MUFFINS | Bio-Logic Systems Corp. | Oct 15, 2001 | SESE |
| K012011 | MODIFICATION TO A620 EEG | Stoelting Co. | Oct 10, 2001 | SESE |
| K011964 | 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
