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) → SEN — Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety

# SEN · Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety

_Neurology · 21 CFR 882.5050 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/SEN

## Overview

- **Product Code:** SEN
- **Device Name:** Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K233337](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/SEN/K233337.md) | Freespira Breathing System | Freespira, Inc. | Apr 24, 2025 | SESE |

## Top Applicants

- Freespira, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/SEN](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/SEN)

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