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Advantage Rail: Bariatric

Healthcraft Products Inc. · Model AR-T-HD · UDI-DI 00689281001304

IKX
10
510(k) clearances
2,540
Adverse events (25 deaths)
20
Recalls
280
Facilities

Description

The Advantage Rail 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. It is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Rail 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 to optimize the user’s range of motion. The maximum user weight is 450lbs / 205kgs. Note: Product is not intended to support full body weight.

Recalls

DateFirmReason
2024-11-05NOA Medical Industries IncRed button used to engage side rails can break or become stuck making it difficult to engage the side rail.
2020-09-15Medline Industries IncThe buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
2017-08-10Medline Industries IncThe 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.
2017-08-10Medline Industries IncThe 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.
2017-05-30EOS ImagingROTH 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
2015-03-26Handicare USA, Inc.Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
2014-04-15Handicare 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
2012-03-20North Coast Medical IncDue 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
2009-07-09Nutech Manufacturing CorpSafety chair used in shower/bath may not meet specifications for weight load.
2009-07-09Nutech Manufacturing CorpSafety 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.