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PHS - L

medica - Medizintechnik GmbH · Model GBS 01.YY.ZZ · UDI-DI 04041925006148

510(k) clearances

Adverse events

Recalls

Facilities

Description

The PHS is a support belt for weight relief, stabilization and fall protection for patients in therapeutic training equipment, e.g. for gait training, treadmills or ceiling systems. The attachment points are located above the head and stabilization points at hip height.

Recalls

Date	Firm	Reason
2023-05-31	Trexo Robotics Holdings Inc.	Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.
2020-06-08	Hocoma AG	The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrol
2013-12-03	MedX Holdings, Inc.	Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
2012-05-05	Interactive Motion Technologies, Inc.	Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.

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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.