FDA.reportPublic FDA data

" Invisia™ SerenaSeat™ (Chrome Plate, 26""/66cm, Walnut Stain)"

Primary DI
00689281031417
Brand
" Invisia™ SerenaSeat™ (Chrome Plate, 26""/66cm, Walnut Stain)"
Company
Healthcraft Products Inc.
Model
INV-WS26-WNT-CRP
Catalog number
03141
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
00689281031417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00689281031417006892810314176892810314170689281031417

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
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
00689281037211PLUS Shampoo Shelf + Grab Bar, Oil Rubbed BronzePLUS-SHS-ORB037212024-01-29
10689281037225PLUS Corner Shelf + Grab Bar, Oil Rubbed BronzePLUS-CS-ORB 037222024-01-29
10689281037232PLUS Towel Bar + Grab Bar, Oil Rubbed BronzePLUS-TB24-ORB 037232024-01-29
10689281037249PLUS Towel Hook, Oil Rubbed BronzePLUS-TH-ORB037242024-01-29
10689281037256PLUS Towel Ring + Grab Bar, Oil Rubbed BronzePLUS-TR-ORB037252024-01-29
10689281037263PLUS Toilet Paper Holder, Oil Rubbed BronzePLUS-TP-ORB 037262024-01-29
10689281037300Easy Mount™ Grab Bar, 1.25x12", Oil Rubbed BronzeGB-12-ORB 037302024-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00689281037334"Easy Mount™ Grab Bar, 1.25x12"", Brushed Stainless"Healthcraft Products Inc.IKX2026-04-14
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
10194484320949CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320956CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320963CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320970CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320987CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320994CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321007CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321014CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321021CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321038CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321045CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321052CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321069CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30