# K082634: Vertigone BPPV Goggle

- Pathway: 510(k) (Traditional)
- Applicant: Vertigone, Inc.
- Decided: Apr 7, 2009 after 209 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070085: Balance Rehabilitation Unit (Bru), Medicaa (Uruguay) S.A. (2007) Summary page 2.

## Indications for use
The VertiGONE goggle is indicated for the treatment of Benign Paroxysmal Positional Vertigo (BPPV). The VertiGONE goggle guides the practitioner to move the patient's head accurately through the Epley, or canalith repositioning maneuver.

Source page: https://510kreport.com/device/K082634
Methodology: https://510kreport.com/methodology