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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2024 | RONAN MEDICAL LLC BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control Open, Classified |
HCC | None listed |
| Jul 7, 2017 | Ondamed Inc Ondamed Biofeedback Device, Model No. 001-00-0101
The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use. Terminated |
HCC | None listed |
| Oct 1, 2015 | Powers Medical Devices, LLC The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed t Open, Classified |
HCC | K151050 |
| Dec 17, 2012 | EEG Info EEG NeuroAmp, Model Number: CS 10090; CS 10137.
Biofeedback and Relaxation Terminated |
HCC | K073557 |
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