SEN · Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety
Neurology · 21 CFR 882.5050 · Class 2
Overview
| Product Code | SEN |
|---|---|
| Device Name | Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233337 | Freespira Breathing System | Freespira, Inc. | Apr 24, 2025 | SESE |
Top Applicants
- Freespira, Inc. — 1 clearance
