---
kind: "section"
citation: "21 C.F.R. § 882.5893"
title: "21"
number: "882.5893"
heading: "Thermal vestibular stimulator for headache."
url: "https://uscodex.org/cfr/21/882.5893"
---

# §882.5893. Thermal vestibular stimulator for headache.

- (a) **Identification.** The thermal vestibular stimulator for headache is a prescription device used to stimulate the vestibular system by applying thermal waveforms through earpieces placed in a patient's ear canal for the treatment of headache.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (2) Performance testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety.
  - (3) The technical parameters of the device, including waveform outputs and temperature limits, must be identified.
  - (4) Cleaning validation of earpieces must be conducted.
  - (5) Software verification, validation, and hazard analysis must be performed.
  - (6) Labeling must include the following:
    - (i) Information on how the device operates and the typical sensations experienced during treatment;
    - (ii) A detailed summary of the device's technical parameters; and
    - (iii) **Instructions for maintenance and cleaning of the device.**

## Notes

### Amendments

[83 FR 52973, Oct. 19, 2018]

### 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

[83 FR 52973, Oct. 19, 2018]