# K220231: GyroStim

- Pathway: 510(k) (Traditional)
- Applicant: Ultrathera Technologies, Inc.
- Decided: Apr 27, 2022 after 90 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: 3 generations back to K946229 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071973: Epley Omniax, Vesticon (2008) Summary page 4.

## Indications for use
The GyroStim is intended to assist in the treatment of balance disorders and vestibular dysfunction in adult patients, age 18 and older, up to 4001b. It is intended to be used by a trained medical professional as prescribed by physician in a clinical environment.

Source page: https://510kreport.com/device/K220231
Methodology: https://510kreport.com/methodology