Apparatus, Vestibular Analysis
The Vestibular Analysis Apparatus (product code LXV) is a diagnostic device used to evaluate the function of the vestibular system of the inner ear, assisting in diagnosing conditions such as vertigo, dizziness, and balance disorders. It is currently unclassified (Class U) with no assigned regulation number or formal medical specialty, and is reviewed under the Ear, Nose, Throat (EN) panel. As an unclassified device, its regulatory pathway has not been fully determined. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- LXV
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 22 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220231 | GyroStim | Apr 27, 2022 | Substantially Equivalent | Ultrathera Technologies, Inc. |
| K200529 | Orion | Aug 12, 2020 | Substantially Equivalent | Interacoustics A/S |
| K192652 | TRV | May 27, 2020 | Substantially Equivalent | Interacoustics A/S |
| K183661 | ClearEdge Balance System | Oct 22, 2019 | Substantially Equivalent | Quadrant Biosciences |
| K190735 | EQ Balance | Aug 16, 2019 | Substantially Equivalent | Upright Science, Inc. |
| K173669 | K-D Balance | Apr 02, 2018 | Substantially Equivalent | King-Devick Technologies, Inc. |
| K121590 | VESTIBULAR ANALYSIS APPARATUS | Sep 20, 2012 | Substantially Equivalent | Capacity Sports, LLC |
| K102364 | NYDIAG 200 | Dec 23, 2010 | Substantially Equivalent | Interacoustics A/S |
| K082634 | VERTIGONE BPPV GOGGLE | Apr 07, 2009 | Substantially Equivalent | Vertigone, Inc. |
| K081602 | DIZZYFIX | Sep 19, 2008 | Substantially Equivalent | Clearwater Clinical Limited |
| K071973 | EPLEY OMNIAX | Jun 20, 2008 | Substantially Equivalent | Vesticon |
| K070676 | KOREBALANCE (KINESTHETIC ABILITY TRAINER) | Apr 18, 2007 | Substantially Equivalent | Sportkat, LLC |
| K070085 | BALANCE REHABILITATION UNIT (BRU) | Feb 26, 2007 | Substantially Equivalent | Medicaa (Uruguay) S.A. |
| K971549 | VMT SYSTEM | Oct 05, 1998 | Substantially Equivalent | Target Health, Inc. |
| K922037 | SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR | Oct 26, 1992 | Substantially Equivalent | Micromedical Technologies, Inc. |
| K911795 | KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) | Nov 19, 1991 | Substantially Equivalent | Breg, Inc. |
| K891008 | VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) | May 31, 1989 | Substantially Equivalent | Micromedical Technologies, Inc. |
| K884926 | BALANCE SYSTEM | Feb 27, 1989 | Substantially Equivalent | Chattanooga Group, Inc. |
| K872093 | RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING | Sep 16, 1987 | Substantially Equivalent | Ics Medical Corp. |
| K851744 | EQUITEST | Aug 05, 1985 | Substantially Equivalent | Neurocom International, Inc. |
| K781268 | CHAIR, VESTIBULAR, ROTARY, COMPUT. | Aug 14, 1978 | Substantially Equivalent | Contraves |
| K771618 | COMPUTERIZED POSTURE PLATFORM | Sep 12, 1977 | Substantially Equivalent | Contraves Goerz Corp. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.