Product code LXV
- Device name
- Apparatus, Vestibular Analysis
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220231 | GyroStim | Ultrathera Technologies, Inc. | 2022-04-27 |
| K200529 | Orion | Interacoustics A/S | 2020-08-12 |
| K192652 | TRV | Interacoustics A/S | 2020-05-27 |
| K183661 | ClearEdge Balance System | Quadrant Biosciences | 2019-10-22 |
| K190735 | EQ Balance | Upright Science, Inc. | 2019-08-16 |
| K173669 | K-D Balance | King-Devick Technologies, Inc. | 2018-04-02 |
| K121590 | VESTIBULAR ANALYSIS APPARATUS | Capacity Sports, LLC | 2012-09-20 |
| K102364 | NYDIAG 200 | Interacoustics A/S | 2010-12-23 |
| K082634 | VERTIGONE BPPV GOGGLE | Vertigone, Inc. | 2009-04-07 |
| K081602 | DIZZYFIX | Clearwater Clinical Limited | 2008-09-19 |
| K071973 | EPLEY OMNIAX | Vesticon | 2008-06-20 |
| K070676 | KOREBALANCE (KINESTHETIC ABILITY TRAINER) | Sportkat, LLC | 2007-04-18 |
| K070085 | BALANCE REHABILITATION UNIT (BRU) | Medicaa (Uruguay) S.A. | 2007-02-26 |
| K971549 | VMT SYSTEM | Target Health, Inc. | 1998-10-05 |
| K922037 | SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR | Micromedical Technologies, Inc. | 1992-10-26 |
| K911795 | KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) | Breg, Inc. | 1991-11-19 |
| K891008 | VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) | Micromedical Technologies, Inc. | 1989-05-31 |
| K884926 | BALANCE SYSTEM | Chattanooga Group, Inc. | 1989-02-27 |
| K872093 | RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING | Ics Medical Corp. | 1987-09-16 |
| K851744 | EQUITEST | Neurocom International, Inc. | 1985-08-05 |
| K781268 | CHAIR, VESTIBULAR, ROTARY, COMPUT. | Contraves | 1978-08-14 |
| K771618 | COMPUTERIZED POSTURE PLATFORM | Contraves Goerz Corp. | 1977-09-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00858458007870 | Korebalance Mobile | Diversified Healthcare Development, LLC | 2026-04-21 |
| 00868168000306 | Sway | HEALTHY ROSTER LLC | 2026-04-13 |
| 00199874750514 | K-D Balance | King-Devick Test, Inc. | 2026-03-03 |
| 00858458007009 | Korebalance Premiere | Diversified Healthcare Development, LLC | 2023-07-31 |
| 05711117219098 | Interacoustics | Interacoustics A/S | 2020-05-29 |