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PHTSIOGAIT US

MEDEN INMED SP Z O O · Model non-AC-powerd · UDI-DI 05903684803286

FSA

510(k) clearances

15,789

Adverse events (432 deaths)

142

Recalls

206

Facilities

Description

PhysioGait Dynamic Partial Weight Bearing system is intended to accomplish dynamic patient support used in the rehabilitation and gait reeducation. The device is used for therapeutic and diagnostic purposes (training balance and gait). It is ideal for working with neurological and orthopedic patients, both adults and children.

Recalls

Date	Firm	Reason
2026-09-14	Baxter Healthcare Corporation	Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quic
2026-03-10	ARJOHUNTLEIGH POLSKA Sp. z.o.o.	An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss
2025-12-18	Community Products, LLC	Potential for fraying on the body support strap.
2025-12-18	Community Products, LLC	Potential for fraying on the body support strap.
2025-12-18	Community Products, LLC	Potential for fraying on the body support strap.
2025-11-17	ETAC A/S	A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it b
2025-11-17	ETAC A/S	A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it b
2025-11-17	ETAC A/S	A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it b
2025-11-17	ETAC A/S	A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it b
2025-05-30	Baxter Healthcare Corporation	The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury fro

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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.