FDA.reportPublic FDA data

"Invisia™ SerenaSeat™ (Oil Rubbed Bronze, 18""/46cm, Honey Stain)"

Primary DI
00689281033961
Brand
"Invisia™ SerenaSeat™ (Oil Rubbed Bronze, 18""/46cm, Honey Stain)"
Company
Healthcraft Products Inc.
Model
INV-WS18-HNY-ORB
Catalog number
03396
Device 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 handle will not inadvertently lower when it is in the up position. 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).
Published
2021-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00689281033961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00689281033961006892810339616892810339610689281033961

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
252468293
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00689281031875Dependa-Bar, Brushed Stainless SteelDBT-BS031872026-09-22
00689281037372Dependa-Bar, Polished ChromeDBT-CP037372026-09-22
00689281037389Dependa-Bar, Smooth WhiteDBT-SW037382026-09-22
00689281037457PLUS Shampoo Shelf 24 + Grab Bar, Matte BlackPLUS-SHS24-BLK037452026-09-22
00689281037464PLUS Shampoo Shelf 24 + Grab Bar, Brushed StainlessPLUS-SHS24-BS037462026-09-22
00689281037471PLUS Shampoo Shelf 24 + Grab Bar, Chrome PolishedPLUS-SHS24-CP037472026-09-22
00689281039598PLUS Shampoo Shelf 24 + Grab Bar, Oil Rubbed BronzePLUS-SHS24-ORB039592026-09-22
00689281037334"Easy Mount™ Grab Bar, 1.25x12"", Brushed Stainless"GB-12-BS037342026-04-14
00689281010382e2™ Ceiling Mount Trapeze with 24 in. Grab BarSTP-CM-24010382021-08-25
00689281010450e2™ Ceiling Mount Trapeze with 32 in. Grab BarSTP-CM-32010452021-08-25
00689281037204PLUS Crescent Grab Bar, Oil Rubbed BronzePLUS-CGB-ORB037202024-01-29
00689281037228PLUS Corner Shelf + Grab Bar, Oil Rubbed BronzePLUS-CS-ORB 037222024-01-29
00689281037235PLUS Towel Bar + Grab Bar, Oil Rubbed BronzePLUS-TB24-ORB 037232024-01-29
00689281037242PLUS Towel Hook, Oil Rubbed BronzePLUS-TH-ORB037242024-01-29
00689281037259PLUS Towel Ring + Grab Bar, Oil Rubbed BronzePLUS-TR-ORB037252024-01-29
00689281037266PLUS Toilet Paper Holder, Oil Rubbed BronzePLUS-TP-ORB 037262024-01-29
00689281037303"Easy Mount™ Grab Bar, 1.25x12"", Oil Rubbed Bronze"GB-12-ORB 037302024-01-29
00689281037310"Easy Mount™ Grab Bar, 1.25x18"", Oil Rubbed Bronze"GB-18-ORB037312024-01-29
00689281037327"Easy Mount™ Grab Bar, 1.25x24"", Oil Rubbed Bronze"GB-24-ORB037322024-01-29
10689281037201PLUS Crescent Grab Bar, Oil Rubbed BronzePLUS-CGB-ORB037202024-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00689281031875Dependa-Bar, Brushed Stainless SteelHealthcraft Products Inc.IKX2026-09-22
00689281037372Dependa-Bar, Polished ChromeHealthcraft Products Inc.IKX2026-09-22
00689281037389Dependa-Bar, Smooth WhiteHealthcraft Products Inc.IKX2026-09-22
00689281037457PLUS Shampoo Shelf 24 + Grab Bar, Matte BlackHealthcraft Products Inc.IKX2026-09-22
00689281037464PLUS Shampoo Shelf 24 + Grab Bar, Brushed StainlessHealthcraft Products Inc.IKX2026-09-22
00689281037471PLUS Shampoo Shelf 24 + Grab Bar, Chrome PolishedHealthcraft Products Inc.IKX2026-09-22
00689281039598PLUS Shampoo Shelf 24 + Grab Bar, Oil Rubbed BronzeHealthcraft Products Inc.IKX2026-09-22
06975996304064Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
06975996304071Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
06975996304088Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
06975996304095Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
06975996304101Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
00810226441989ViveVIVE HEALTH LLCIKX2026-08-14
06974021419490EQUATEWAL-MART STORES, INC.IKX2026-07-31
10194484320772CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320789CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320796CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320802CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320819CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320826CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320833CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320840CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320857CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320864CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320871CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320895CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320901CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320918CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320925CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320932CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30