FDA.reportPublic FDA data

Invisia™ SerenaSeat™ Polymer, 18" Wide, Cream Seat, Silver Frame

Primary DI
00689281037587
Brand
Invisia™ SerenaSeat™ Polymer, 18" Wide, Cream Seat, Silver Frame
Company
Healthcraft Products Inc.
Model
INV-WSPE-18-CRM-SLVR
Catalog number
03758
Device description
The SerenaSeat is a high quality, commercial grade, fold down shower seat. The SerenaSeat is intended to provide shower seating support for people with disability. The SerenaSeat 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 SerenaSeat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The SerenaSeat should be installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Serena-Seat is not to be used in any other way than described.
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00689281037587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00689281037587006892810375876892810375870689281037587

GMDN Terms#

Term, Definition table
TermDefinition
Shower seat, non-poweredA non-powered device designed to be sat upon by a patient (adult or child) while washing in a shower, or other washing facility (e.g., bath). The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device may be in the form of a portable chair/stool or a fixed seat (e.g., wall-mounted), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials (e.g., plastic and metal-coated materials). It may be used in a hospital, institution, or home.

Regulatory Flags#

DUNS number
252468293
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00689281038416Easy Mount™ Grab Bar, 1.25x12", Knurled (BAG)GB-12-SK-BAG038412026-10-01
00689281038423Easy Mount™ Grab Bar, 1.25x18", Knurled (BAG)GB-18-SK-BAG038422026-10-01
00689281038430Easy Mount™ Grab Bar, 1.25x24", Knurled (BAG)GB-24-SK-BAG038432026-10-01
00689281038447Easy Mount™ Grab Bar, 1.25x32", Knurled (BAG)GB-32-SK-BAG038442026-10-01
00689281039253Easy Mount™ Grab Bar, 1.25x12", Matte Black (Textured)GB-12-BLK-T039252026-10-01
00689281039260Easy Mount™ Grab Bar, 1.25x24", Matte Black (Texture)GB-24-BLK-T039262026-10-01
00689281008006Easy Mount™ Grab Bar, 1.25x18", Matte BlackGB-18-BLK008002026-09-30
00689281008013Easy Mount™ Grab Bar, 1.25x24", Matte BlackGB-24-BLK008012026-09-30
00689281008020Easy Mount™ Grab Bar, 1.25x12", PolishedGB-12-CP008022026-09-30
00689281008037Easy Mount™ Grab Bar, 1.25x18", PolishedGB-18-CP008032026-09-30
00689281008044Easy Mount™ Grab Bar, 1.25x24", PolishedGB-24-CP008042026-09-30
00689281008082Easy Mount™ Grab Bar, 1.25x12", KnurledGB-12-SK008082026-09-30
00689281008099Easy Mount™ Grab Bar, 1.25x18", KnurledGB-18-SK008092026-09-30
00689281008105Easy Mount™ Grab Bar, 1.25x24", KnurledGB-24-SK008102026-09-30
00689281008112Easy Mount™ Grab Bar, 1.25x32", KnurledGB-32-SK008112026-09-30
00689281008129Easy Mount™ Grab Bar, 1.25x36", KnurledGB-36-SK008122026-09-30
00689281008136Easy Mount™ Grab Bar, 1.25x42", KnurledGB-42-SK008132026-09-30
00689281008143Easy Mount™ Grab Bar, 1.25x12", WhiteGB-12-SW008142026-09-30
00689281008150Easy Mount™ Grab Bar, 1.25x18", WhiteGB-18-SW008152026-09-30
00689281008167Easy Mount™ Grab Bar, 1.25x24", WhiteGB-24-SW008162026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00689281038416Easy Mount™ Grab Bar, 1.25x12", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038423Easy Mount™ Grab Bar, 1.25x18", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038430Easy Mount™ Grab Bar, 1.25x24", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038447Easy Mount™ Grab Bar, 1.25x32", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281039253Easy Mount™ Grab Bar, 1.25x12", Matte Black (Textured)Healthcraft Products Inc.IKX2026-10-01
00689281039260Easy Mount™ Grab Bar, 1.25x24", Matte Black (Texture)Healthcraft Products Inc.IKX2026-10-01
00689281008006Easy Mount™ Grab Bar, 1.25x18", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008013Easy Mount™ Grab Bar, 1.25x24", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008020Easy Mount™ Grab Bar, 1.25x12", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008037Easy Mount™ Grab Bar, 1.25x18", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008044Easy Mount™ Grab Bar, 1.25x24", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008082Easy Mount™ Grab Bar, 1.25x12", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008099Easy Mount™ Grab Bar, 1.25x18", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008105Easy Mount™ Grab Bar, 1.25x24", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008112Easy Mount™ Grab Bar, 1.25x32", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008129Easy Mount™ Grab Bar, 1.25x36", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008136Easy Mount™ Grab Bar, 1.25x42", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008143Easy Mount™ Grab Bar, 1.25x12", WhiteHealthcraft Products Inc.IKX2026-09-30
00689281008150Easy Mount™ Grab Bar, 1.25x18", WhiteHealthcraft Products Inc.IKX2026-09-30
00689281008167Easy Mount™ Grab Bar, 1.25x24", WhiteHealthcraft Products Inc.IKX2026-09-30
00689281008174Easy Mount™ Grab Bar, 1.25x32", WhiteHealthcraft Products Inc.IKX2026-09-30
00689281008181Easy Mount™ Grab Bar, 1.25x36", WhiteHealthcraft Products Inc.IKX2026-09-30
00689281008198Easy Mount™ Grab Bar, 120 degree, 1.25x24x24", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008204Easy Mount™ Grab Bar, 90 degree, 1.25x30x30", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008211Easy Mount™ Grab Bar, 1.25x12", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281037341Easy Mount™ Grab Bar, 1.25x18", Brushed StainlessHealthcraft Products Inc.IKX2026-09-30
00689281037358Easy Mount™ Grab Bar, 1.25x24", Brushed StainlessHealthcraft Products Inc.IKX2026-09-30
00689281039543Easy Mount™ Grab Bar, 90 degree, 1.25x30x30", Oil Rubbed BronzeHealthcraft Products Inc.IKX2026-09-30
00689281037488Invisia™ SerenaSeat™ Polymer, 18" Wide, Beige Seat, Matte Black FrameHealthcraft Products Inc.IKX2026-09-29
00689281037495Invisia™ SerenaSeat™ Polymer, 18" Wide, Beige Seat, Oil Rubbed Bronze FrameHealthcraft Products Inc.IKX2026-09-29