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Advantage Pole™ Portable Bariatric

Healthcraft Products Inc. · Model AR-AP-P-HD · UDI-DI 00689281000550

IKX

510(k) clearances

2,540

Adverse events (25 deaths)

Recalls

282

Facilities

Description

The Advantage Rail Portable is a high quality, commercial grade pivoting and locking horizontal bar that connects to a floor mounted mast. The horizontal bar can be lifted, pivoted and lowered to the next locking position around the mast. The Advantage Rai Portable is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Rail Portable mast is installed to a structural floor. Inside the mast is a locking mechanism for the horizontal bar: a castellated collar with 8 grooves (every 45 degrees) to provide a mechanism strong enough to support the user. It is important to set proper height and orientation of the Advantage Rail Portable to optimize the user’s range of motion. The maximum user weight is dependent on model. Note: Product is not intended to support full body weight. The Advantage Rail Portable is not to be used in any other way than described above. The Advantage Pole Portable is a high quality, commercial grade floor mounted support pole. The Advantage Pole Portable is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Pole Portable mast is installed to a structural floor. The maximum user weight is dependent on model. Note: Product is not intended to support full body weight.

Recalls

Date	Firm	Reason
2024-11-05	NOA Medical Industries Inc	Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.
2020-09-15	Medline Industries Inc	The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
2017-08-10	Medline Industries Inc	The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
2017-08-10	Medline Industries Inc	The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
2017-05-30	EOS Imaging	ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety i
2015-03-26	Handicare USA, Inc.	Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
2014-04-15	Handicare USA, Inc.	During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of
2012-03-20	North Coast Medical Inc	Due to a consumer complaint, North Coast Medical determined that due to a design flaw, there was not enough plastic support material to retain bracket bolts when subjected to a for
2009-07-09	Nutech Manufacturing Corp	Safety chair used in shower/bath may not meet specifications for weight load.
2009-07-09	Nutech Manufacturing Corp	Safety chair used in shower/bath may not meet specifications for weight load.

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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.