# K042529: Balanceback VNG System

- Pathway: 510(k) (Traditional)
- Applicant: Fall Prevention Technologies, LLC
- Decided: Oct 6, 2004 after 19 days
- Product code: GWN (Nystagmograph)
- Device class: 2
- Regulation: 21 CFR 882.1460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925111 (1994). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925111: House Infrared/Video Electronystagmograph System, Eye Dynamics, Inc. (1994) Summary page 1.
- K972243: 2D Vog - Video-Oculography, Sensomotoric Instruments, GmbH (1997) Summary page 1.

## Most influential descendants
- K070729: Balanceback Mobile Intuitive VNG System (2007), 2 descendants of its own
- K152915: Eye-Sync (2016), 1 descendant of its own
- K181771: RightEye Vision System (2018), 0 descendants of its own
- K130201: Nystagram Video Nystagmography System (2013), 0 descendants of its own
- K062015: Chronos Vision Eye Tracking Device (C-Etd) (2006), 0 descendants of its own

## Indications for use
The BalanceBack VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The VNG is intended for use only by trained physicians or clinicians in an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.

Source page: https://510kreport.com/device/K042529
Methodology: https://510kreport.com/methodology