Apparatus, Vestibular Analysis
FDA product code LXV · Unclassified · Ear, Nose, Throat
22510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Interacoustics A/S 3
- Micromedical Technologies, Inc. 2
- Sportkat, LLC 1
- Ultrathera Technologies, Inc. 1
- Quadrant Biosciences 1
- Upright Science, Inc. 1
- King-Devick Technologies, Inc. 1
- Capacity Sports, LLC 1
- Vertigone, Inc. 1
- Clearwater Clinical Limited 1
- Vesticon 1
- Contraves Goerz Corp. 1
- Medicaa (Uruguay) S.A. 1
- Target Health, Inc. 1
- Breg, Inc. 1
- Chattanooga Group, Inc. 1
- Ics Medical Corp. 1
- Neurocom International, Inc. 1
- Contraves 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220231 | GyroStimLXV · Traditional | Ultrathera Technologies, Inc. | 04/27/2022SE |
| K200529 | OrionLXV · Traditional | Interacoustics A/S | 08/12/2020SE |
| K192652 | TRVLXV · Traditional | Interacoustics A/S | 05/27/2020SE |
| K183661 | ClearEdge Balance SystemLXV · Traditional | Quadrant Biosciences | 10/22/2019SE |
| K190735 | EQ BalanceLXV · Traditional | Upright Science, Inc. | 08/16/2019SE |
| K173669 | K-D BalanceLXV · Traditional | King-Devick Technologies, Inc. | 04/02/2018SE |
| K121590 | Vestibular Analysis ApparatusLXV · Traditional | Capacity Sports, LLC | 09/20/2012SE |
| K102364 | Nydiag 200LXV · Traditional | Interacoustics A/S | 12/23/2010SE |
| K082634 | Vertigone BPPV GoggleLXV · Traditional | Vertigone, Inc. | 04/07/2009SE |
| K081602 | DizzyfixLXV · Traditional | Clearwater Clinical Limited | 09/19/2008SE |
| K071973 | Epley OmniaxLXV · Traditional | Vesticon | 06/20/2008SE |
| K070676 | Korebalance (Kinesthetic Ability Trainer)LXV · Special | Sportkat, LLC | 04/18/2007SE |
| K070085 | Balance Rehabilitation Unit (Bru)LXV · Traditional | Medicaa (Uruguay) S.A. | 02/26/2007SE |
| K971549 | VMT SystemLXV · Traditional | Target Health, Inc. | 10/05/1998SE |
| K922037 | System 2000, Rotational Vestibular ChairLXV · Traditional | Micromedical Technologies, Inc. | 10/26/1992SE |
| K911795 | Kinesthetic Ability Trainer (K.A.T., Model 1000)LXV · Traditional | Breg, Inc. | 11/19/1991SE |
| K891008 | Vestibular Ocular Reflex Test Equipment(Vorteq)LXV · Traditional | Micromedical Technologies, Inc. | 05/31/1989SE |
| K884926 | Balance SystemLXV · Traditional | Chattanooga Group, Inc. | 02/27/1989SE |
| K872093 | RVT-50 Rotary Chair for Vestibular TestingLXV · Traditional | Ics Medical Corp. | 09/16/1987SE |
| K851744 | EquitestLXV · Traditional | Neurocom International, Inc. | 08/05/1985SE |
| K781268 | Chair, Vestibular, Rotary, Comput.LXV · Traditional | Contraves | 08/14/1978SE |
| K771618 | Computerized Posture PlatformLXV · Traditional | Contraves Goerz Corp. | 09/12/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2253-2009 | VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used…Marketed without a 510k or PMA submission to include the normative data display. | Neuro Kinetics | 07/24/2009Terminated |
| Z-2348-2008 | Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being…The firm distributed an unapproved medical device. | Acacia Engineered Products LLC | 07/09/2008Terminated |