# K070729: Balanceback Mobile Intuitive VNG System

- Pathway: 510(k) (Traditional)
- Applicant: Fall Prevention Technologies, LLC
- Decided: Mar 30, 2007 after 15 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: 2 generations back to K925111 (1994). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042529: Balanceback VNG System, Fall Prevention Technologies, LLC (2004) Summary page 1.

## Most influential descendants
- K152915: Eye-Sync (2016), 1 descendant of its own
- K181771: RightEye Vision System (2018), 0 descendants of its own

## Indications for use
The balanceback TM Mobile Intuitive VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The Mobile iVNG 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/K070729
Methodology: https://510kreport.com/methodology