| Device Type ID | 3721 |
| Device Name | Device, Biofeedback |
| Regulation Description | Biofeedback Device. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 882.5050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HCC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3721 |
| Device | Device, Biofeedback |
| Product Code | HCC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Biofeedback Device. |
| CFR Regulation Number | 882.5050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PALO ALTO HEALTH SCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ondamed Inc | II | May-10-2018 |
| 2 | Powers Medical Devices, LLC | II | Dec-08-2015 |