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Folding Shower Seat

Healthcraft Products Inc. · Model FDS-S · UDI-DI 00689281035262

IKX

510(k) clearances

2,515

Adverse events (25 deaths)

Recalls

281

Facilities

Description

The Fold Down Seat is a high quality, commercial grade, fold down shower seat. The Fold Down Seat is intended to provide shower seating support for people with reduced mobility. The Fold Down Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Fold Down Seat is intended to be folded up when not in use. The hinge allows the seat to open slowly, and lock against the wall in the folded position. The Fold Down Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 440lbs / 200kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Fold Down Seat is not to be used in any other way than described above.

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.