Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart B — Diagnostic Devices](/submissions/EN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 874.1800](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1800) → ETP — Stimulator, Caloric-Water

# ETP · Stimulator, Caloric-Water

_Ear, Nose, Throat · 21 CFR 874.1800 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP

## Overview

- **Product Code:** ETP
- **Device Name:** Stimulator, Caloric-Water
- **Regulation:** [21 CFR 874.1800](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1800)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K863615](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP/K863615.md) | ENTHERMO IRRIGATION UNIT | Jedmed Instrument Co. | Dec 16, 1986 | SESE |
| [K820775](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP/K820775.md) | VESTIBULARISET | Jedmed Instrument Co. | Nov 3, 1982 | SESE |
| [K821481](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP/K821481.md) | NASAL-THROAT SPRAY IRRIGATION INSTRUM. | Ethicare Products | Jun 14, 1982 | SESE |
| [K813552](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP/K813552.md) | MODEL 3000C CALORIC IRRIGATOR | Life-Tech Intl., Inc. | Feb 22, 1982 | SESE |
| [K800443](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP/K800443.md) | HYGROTHERM | Jedmed Instrument Co. | Mar 10, 1980 | SESE |
| [K800442](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP/K800442.md) | VARIOTHERM | Jedmed Instrument Co. | Mar 10, 1980 | SESE |

## Top Applicants

- Jedmed Instrument Co. — 4 clearances
- Ethicare Products — 1 clearance
- Life-Tech Intl., Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP)

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