---
kind: "section"
citation: "21 C.F.R. § 874.1800"
title: "21"
number: "874.1800"
heading: "Air or water caloric stimulator."
url: "https://uscodex.org/cfr/21/874.1800"
---

# §874.1800. Air or water caloric stimulator.

- (a) **Identification.** An air or water caloric stimulator is a device that delivers a stream of air or water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produce involuntary eye movements that are measured and recorded by a nystagmograph.
- (b) **Classification.** Class I (general controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 874.9](/cfr/21/874.9.md).

## Notes

### Amendments

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]

### Authority

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

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

### Amendments

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]