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e2™ Trapeze Handle & Strap

Healthcraft Products Inc. · Model STP-HS · UDI-DI 00689281020428

IKX
10
510(k) clearances
2,540
Adverse events (25 deaths)
20
Recalls
281
Facilities

Description

The e2 Ceiling Mount Trapeze is an over-bed trapeze system that secures to the ceiling. The trapeze handle features two offset ladder rungs to allow for improved use of arm strength and increased comfort. Additionally, it can slide sideward / laterally on the ceiling mounted grab bar to store out of the way when not in use. The e2 Ceiling Mount Trapeze is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. The grab bar is installed to a structural ceiling, and a metal hook is looped onto the grab bar. The trapeze handle is connected with an adjustable strap to the metal hook. The maximum user weight for this product is 300lbs / 136kgs. No more than 150lbs / 68kgs is to be exerted on the e2 trapeze (sitting support only). NOTE: Product is not intended to support full body weight. The e2 Ceiling Mount Trapeze is not to be used in any other way than described.

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.