# K071973: Epley Omniax

- Pathway: 510(k) (Traditional)
- Applicant: Vesticon
- Decided: Jun 20, 2008 after 339 days
- Product code: LXV (Apparatus, Vestibular Analysis)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K946229 (1995). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964325: Visualeyes: Video Eye Monitor, Micromedical Technologies, Inc. (1997) Summary page 1.
- K863424: Computer Eye Tracking Sys./Eng Exam. Chair & Table, Micromedical Technologies, Inc. (1987) Summary page 1.
- K922037: System 2000, Rotational Vestibular Chair, Micromedical Technologies, Inc. (1992) Summary page 1.
- K070085: Balance Rehabilitation Unit (Bru), Medicaa (Uruguay) S.A. (2007) Summary page 1.

## Most influential descendants
- K220231: GyroStim (2022), 0 descendants of its own
- K192652: TRV (2020), 0 descendants of its own
- K081602: Dizzyfix (2008), 0 descendants of its own

## Indications for use
The Epley Omniax is intended to assist in the diagnosis and treatment of balance disorders and vertigo, including benign paroxysmal positional vertigo.

Source page: https://510kreport.com/device/K071973
Methodology: https://510kreport.com/methodology