# K072887: G-Trainer Medical

- Pathway: 510(k) (Traditional)
- Applicant: Alter-G, Inc.
- Decided: Jan 25, 2008 after 107 days
- Product code: BXB (Exerciser, Powered)
- Device class: 1
- Regulation: 21 CFR 890.5380
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Biodex Medical Systems, Inc. Gait Training System (Gait Trainer 2 treadmill and Unweighing System): named in the summary without a submission number
- (no number) Woodway USA Inc. ProLift 360: named in the summary without a submission number

## Cited in the summary but 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.

## Recalls of this device
- Jul 15, 2011 · Not classified · Z-3026-2011: Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting.

## Indications for use
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.

Source page: https://510kreport.com/device/K072887
Methodology: https://510kreport.com/methodology