510(k) · Cleared
ClearedBalance Rehabilitation Unit (Bru)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicaa (Uruguay) S.A. · LXV Apparatus, Vestibular Analysis
Cleared on Feb 26, 2007 as substantially equivalent to K946229 (Neurocom International, Inc., 1995) after a 48-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- Feb 26, 2007
- Review
- 48 days
- Class
- Class U
- Product code
- LXV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946229 (1995). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK946229 Balance ManagerNeurocom International, Inc. · 1995
- This deviceK070085 Balance Rehabilitation Unit (Bru)Medicaa (Uruguay) S.A. · 2007
- Descendant · cites it directly · 3 of its ownK071973 Epley OmniaxVesticon · 2008
- Descendant · 2 generations on · 0 of its ownK220231 GyroStimUltrathera Technologies, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK192652 TRVInteracoustics A/S · 2020
- Descendant · cites it directly · 0 of its ownK082634 Vertigone BPPV GoggleVertigone, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK081602 DizzyfixClearwater Clinical Limited · 2008
Most influential descendants
Showing 5 of 5 · See all- K071973Epley OmniaxVesticon · 2008 · cites it directly3descendants
- K220231GyroStimUltrathera Technologies, Inc. · 2022 · 2 generations on0descendants
- K192652TRVInteracoustics A/S · 2020 · 2 generations on0descendants
- K082634Vertigone BPPV GoggleVertigone, Inc. · 2009 · cites it directly0descendants
- K081602DizzyfixClearwater Clinical Limited · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946229 | Balance Manager | Neurocom International, Inc. | 1995 | — |
| 0 (this device) | K070085 | Balance Rehabilitation Unit (Bru) | Medicaa (Uruguay) S.A. | 2007 | — |
| +1 | K071973 | Epley Omniax | Vesticon | 2008 | — |
| +2 | K220231 | GyroStim | Ultrathera Technologies, Inc. | 2022 | — |
| +2 | K192652 | TRV | Interacoustics A/S | 2020 | — |
| +1 | K082634 | Vertigone BPPV Goggle | Vertigone, Inc. | 2009 | — |
| +1 | K081602 | Dizzyfix | Clearwater Clinical Limited | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LXV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LXV device
- #1 K220231 GyroStimscore 3.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K946229 | Balance ManagerSummary page 1…tially equivalent to the Balance Manager from Neurocom International, Inc. The Balance Manager was cleared by the FDA on August 4, 1995 under 5 10(k) K946229. IV. Intended Use of the Device Balance Evaluation and Rehabilitation The Balance Rehabilitation Unit… | 1995 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LXV devicesLXV Apparatus, Vestibular Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LXV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LXV
Too few LXV 510(k)s in any year since 2007 to give a median.
Recalls per year · LXV
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXV
1in 2010
MAUDE reports naming product code LXV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070085: Balance Rehabilitation Unit (Bru).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070085
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026