

# LXV · Apparatus, Vestibular Analysis

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/LXV

## Overview

- **Product Code:** LXV
- **Device Name:** Apparatus, Vestibular Analysis
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (20 of 22)

Showing 20 most recent of 22 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K220231](/device/K220231.md) | GyroStim | Ultrathera Technologies, Inc. | Apr 27, 2022 | SESE |
| [K200529](/device/K200529.md) | Orion | Interacoustics A/S | Aug 12, 2020 | SESE |
| [K192652](/device/K192652.md) | TRV | Interacoustics A/S | May 27, 2020 | SESE |
| [K183661](/device/K183661.md) | ClearEdge Balance System | Quadrant Biosciences | Oct 22, 2019 | SESE |
| [K190735](/device/K190735.md) | EQ Balance | Upright Science, Inc. | Aug 16, 2019 | SESE |
| [K173669](/device/K173669.md) | K-D Balance | King-Devick Technologies, Inc. | Apr 2, 2018 | SESE |
| [K121590](/device/K121590.md) | VESTIBULAR ANALYSIS APPARATUS | Capacity Sports, LLC | Sep 20, 2012 | SESE |
| [K102364](/device/K102364.md) | NYDIAG 200 | Interacoustics A/S | Dec 23, 2010 | SESE |
| [K082634](/device/K082634.md) | VERTIGONE BPPV GOGGLE | Vertigone, Inc. | Apr 7, 2009 | SESE |
| [K081602](/device/K081602.md) | DIZZYFIX | Clearwater Clinical Limited | Sep 19, 2008 | SESE |
| [K071973](/device/K071973.md) | EPLEY OMNIAX | Vesticon | Jun 20, 2008 | SESE |
| [K070676](/device/K070676.md) | KOREBALANCE (KINESTHETIC ABILITY TRAINER) | Sportkat, LLC | Apr 18, 2007 | SESE |
| [K070085](/device/K070085.md) | BALANCE REHABILITATION UNIT (BRU) | Medicaa (Uruguay) S.A. | Feb 26, 2007 | SESE |
| [K971549](/device/K971549.md) | VMT SYSTEM | Target Health, Inc. | Oct 5, 1998 | SESE |
| [K922037](/device/K922037.md) | SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR | Micromedical Technologies, Inc. | Oct 26, 1992 | SESE |
| [K911795](/device/K911795.md) | KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) | Breg, Inc. | Nov 19, 1991 | SESE |
| [K891008](/device/K891008.md) | VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) | Micromedical Technologies, Inc. | May 31, 1989 | SESE |
| [K884926](/device/K884926.md) | BALANCE SYSTEM | Chattanooga Group, Inc. | Feb 27, 1989 | SESE |
| [K872093](/device/K872093.md) | RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING | Ics Medical Corp. | Sep 16, 1987 | SESE |
| [K851744](/device/K851744.md) | EQUITEST | Neurocom International, Inc. | Aug 5, 1985 | SESE |

## Top Applicants

- Interacoustics A/S — 3 clearances
- Micromedical Technologies, Inc. — 2 clearances
- Breg, Inc. — 1 clearance
- Capacity Sports, LLC — 1 clearance
- Chattanooga Group, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/LXV](https://fda.innolitics.com/productcode/LXV)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
