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ZeroG Gait & Balance System

ARETECH, LLC · Model ZGGB-V3 · UDI-DI 00850018836012

BXB

510(k) clearances

151

Adverse events

Recalls

118

Facilities

Description

The ZeroG Gait & Balance System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG can also be used to train subjects ambulating on a treadmill. ZeroG should never be used to lift and transport subjects, and should never be connected to inanimate objects. ZeroG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG training competency exam conducted by an Aretech trainer or a certified staff trainer.

Recalls

Date	Firm	Reason
2024-08-01	Btt Health Gmbh	Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical devic
2019-07-29	MOTEK MEDICAL B.V.	The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable gu
2013-06-12	Accelerated Care Plus Corporation	An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.
2012-11-12	BioMotion Medical Systems, LLC	BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involvin
2011-07-15	Alter-G, Incorporated	Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting.
2009-05-27	Hocoma AG	Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.