510(k) · Cleared
Recalled · 2011G-Trainer Medical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alter-G, Inc. · BXB Exerciser, Powered
Cleared on Jan 25, 2008 after a 107-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). It has been recalled once.
- Decided
- Jan 25, 2008
- Review
- 107 days
- Class
- Class I
- Product code
- BXB
- Recalls
- 1
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 BXB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K962358 | Woodway treadmill Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…FDA Device Listing Database under their respective manufacturers names as exempt, Class I devices. Woodway previously submitted a premarket notification (K962358) to the FDA for the treadmill and the FDA found it to be exempt from premarket notification requirements. Device… | |
| * | — | Biodex Medical Systems, Inc. Gait Training System (Gait Trainer 2 treadmill and… Named without a submission number | |
| * | — | Woodway USA Inc. ProLift 360 Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2011 | Not classified | Z-3026-2011 | Device Design | Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All BXB devicesBXB Exerciser, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · BXB
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · BXB
Too few BXB 510(k)s in any year since 2007 to give a median.
Recalls per year · BXB
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BXB
4in 2025
MAUDE reports naming product code BXB, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 1 | 4 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Alter-G G-Trainer is indicated for use in the following conditions:
Aerobic conditioning
Weight control and reduction
Sport specific conditioning programs
Gait training in neurologic patients
Strengthening and conditioning in older patients
Rehabilitation following injury or surgery of the lower extremity
Rehabilitation following injury or surgery of the hip, knee, ankle or foot.
Rehabilitation after total joint replacement
The G-Trainer is to be operated by a clinician, trained assistant or athletic trainer at a clinical or conditioning facility in an adult or young adult population at least 5'4" in stature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072887 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072887: G-Trainer Medical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072887
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026