---
kind: "section"
citation: "21 C.F.R. § 882.5050"
title: "21"
number: "882.5050"
heading: "Biofeedback device."
url: "https://uscodex.org/cfr/21/882.5050"
---

# §882.5050. Biofeedback device.

- (a) **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.
- (b) **Classification.** Class II (special controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) 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](/cfr/21/882.9.md).

## Notes

### Amendments

[44 FR 51730, Sept. 4, 1979, as amended at 63 FR 59229, Nov. 3, 1998]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[44 FR 51730, Sept. 4, 1979, as amended at 63 FR 59229, Nov. 3, 1998]