21 CFR 882.5050 — Device, Biofeedback
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5050
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HCC | Device, Biofeedback | 2 | 172 | |
| LEL | Device, Sleep Assessment | 2 | 19 | |
| SEN | Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety | 2 | 1 |
Special Controls
HCC — Device, Biofeedback
*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.
eCFR
LEL — Device, Sleep Assessment
*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.
eCFR
SEN — Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety
*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.
eCFR
