LXV — Apparatus, Vestibular Analysis Class U
FDA Device Classification
Classification Details
- Product Code
- LXV
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Unknown
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K220231 | ultrathera technologies | GyroStim | April 27, 2022 |
| K200529 | interacoustics | Orion | August 12, 2020 |
| K192652 | interacoustics | TRV | May 27, 2020 |
| K183661 | quadrant biosciences | ClearEdge Balance System | October 22, 2019 |
| K190735 | upright science | EQ Balance | August 16, 2019 |
| K173669 | king-devick technologies | K-D Balance | April 2, 2018 |
| K121590 | capacity sports | VESTIBULAR ANALYSIS APPARATUS | September 20, 2012 |
| K102364 | interacoustics | NYDIAG 200 | December 23, 2010 |
| K082634 | vertigone | VERTIGONE BPPV GOGGLE | April 7, 2009 |
| K081602 | clearwater clinical limited | DIZZYFIX | September 19, 2008 |
| K071973 | vesticon | EPLEY OMNIAX | June 20, 2008 |
| K070676 | sportkat | KOREBALANCE (KINESTHETIC ABILITY TRAINER) | April 18, 2007 |
| K070085 | medicaa (uruguay) | BALANCE REHABILITATION UNIT (BRU) | February 26, 2007 |
| K971549 | target health | VMT SYSTEM | October 5, 1998 |
| K922037 | micromedical technologies | SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR | October 26, 1992 |
| K911795 | breg | KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) | November 19, 1991 |
| K891008 | micromedical technologies | VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) | May 31, 1989 |
| K884926 | chattanooga group | BALANCE SYSTEM | February 27, 1989 |
| K872093 | ics medical | RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING | September 16, 1987 |
| K851744 | neurocom international | EQUITEST | August 5, 1985 |