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HomeHealthcraft Products Inc. › Invisia™ SerenaSeat™ Pro (Polished Chrome, 18"/46cm, Medium)

Invisia™ SerenaSeat™ Pro (Polished Chrome, 18"/46cm, Medium)

Healthcraft Products Inc. · Model INV-WSFD-18-MEDIUM-CP · UDI-DI 00689281035170

IKX
10
510(k) clearances
2,515
Adverse events (25 deaths)
20
Recalls
281
Facilities

Description

The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-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 Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the seat will not inadvertently lower when it is in the up position. To adjust the amount of friction required to fold seat, remove end cap and turn finger nut. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).

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.