# K070085: Balance Rehabilitation Unit (Bru)

- Pathway: 510(k) (Traditional)
- Applicant: Medicaa (Uruguay) S.A.
- Decided: Feb 26, 2007 after 48 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: 1 generation back to K946229 (1995). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946229: Balance Manager, Neurocom International, Inc. (1995) Summary page 1.

## Most influential descendants
- K071973: Epley Omniax (2008), 3 descendants of its own
- K220231: GyroStim (2022), 0 descendants of its own
- K192652: TRV (2020), 0 descendants of its own
- K082634: Vertigone BPPV Goggle (2009), 0 descendants of its own
- K081602: Dizzyfix (2008), 0 descendants of its own

## Indications for use
Balance Evaluation and Rehabilitation The Balance Rehabilitation Unit (BRUTM) is a system that enables the functional assessment and training/retraining of patients with balance disorders, vertigo or instability.

Source page: https://510kreport.com/device/K070085
Methodology: https://510kreport.com/methodology