FDA.reportPublic FDA data

Invisia™ SerenaSeat™ (Matte Black, 26"/66cm, Ash Stain

Primary DI
00689281031738
Brand
Invisia™ SerenaSeat™ (Matte Black, 26"/66cm, Ash Stain
Company
Healthcraft Products Inc.
Model
INV-WS26-ASH-BLK
Catalog number
03173
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
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
00689281031738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00689281031738006892810317386892810317380689281031738

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
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
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
10689281037317Easy Mount™ Grab Bar, 1.25x18", Oil Rubbed BronzeGB-18-ORB037312024-01-29
10689281037324Easy Mount™ Grab Bar, 1.25x24", Oil Rubbed BronzeGB-24-ORB037322024-01-29
00689281031783Invisia Corner Seat, Medium, Grey MatteINV-WSCS-MEDIUM-PCG031782022-12-02
00689281035866SuperPole FRS with SuperBarFRS-SPB035962022-12-02
00689281008228Invisia Shower Bench, 24", Light, BlackINV-WSSB-24-LIGHT-BLK008222022-11-17
00689281008235Invisia Shower Bench, 24", Light, Oil rubbed BronzeINV-WSSB-24-LIGHT-ORB008232022-11-17
00689281008242Invisia Shower Bench, 24", Light, Matte GreyINV-WSSB-24-LIGHT-PCG008242022-11-17
00689281008259Invisia Shower Bench, 24", Light, Matte WhiteINV-WSSB-24-LIGHT-WHT008252022-11-17
00689281008266Invisia Shower Bench, 24", Medium, BlackINV-WSSB-24-MEDIUM-BLK008262022-11-17
00689281008273Invisia Shower Bench, 24", Medium, Matte GreyINV-WSSB-24-MEDIUM-PCG008272022-11-17
00689281035484Invisia Bath Bench, 30", Medium, BlackINV-WSBB-30-MEDIUM-BLK2022-11-17
00689281035491Invisia Bath Bench, 30", Medium, Brushed StainlessINV-WSBB-30-MEDIUM-BS035492022-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00745129278366Sigvaris DOFF N’ DONNER SET – Single UnitSIGVARIS INCIKX2026-03-11
00850015884658easycareSynchronis Medical, LLCIKX2026-02-20
00850015884764easycareSynchronis Medical, LLCIKX2026-02-20
00850015884962easycareSynchronis Medical, LLCIKX2026-02-20
00850015884986easycareSynchronis Medical, LLCIKX2026-02-20
00850063404006easycareSynchronis Medical, LLCIKX2026-02-20
00850063404020easycareSynchronis Medical, LLCIKX2026-02-20
00850063404044easycareSynchronis Medical, LLCIKX2026-02-20
00860000925303easycareSynchronis Medical, LLCIKX2026-02-20
00850063404068easycareSynchronis Medical, LLCIKX2026-02-13
00850063404082easycareSynchronis Medical, LLCIKX2026-02-13
00850063404105easycareSynchronis Medical, LLCIKX2026-02-13
00850063404129easycareSynchronis Medical, LLCIKX2026-02-13
00850063404143easycareSynchronis Medical, LLCIKX2026-02-13
00850063404167easycareSynchronis Medical, LLCIKX2026-02-13
00850063404181easycareSynchronis Medical, LLCIKX2026-02-13
10810132043007HCSConcordance Healthcare Solutions LLCIKX2026-01-23
10810132043014HCSConcordance Healthcare Solutions LLCIKX2026-01-23
00745129273859579 Melany Donning & Doffing SmallSIGVARIS INCIKX2026-01-19
00745129273866579 Melany Donning & Doffing Extra SmallSIGVARIS INCIKX2026-01-19
00745129273835579 Melany Donning & Doffing LargeSIGVARIS INCIKX2026-01-09
00745129273842579 Melany Donning & Doffing MEDIUMSIGVARIS INCIKX2026-01-09
00810178884940ViveVIVE HEALTH LLCIKX2026-01-08
00810178885015ViveVIVE HEALTH LLCIKX2026-01-08
10810178884206ViveVIVE HEALTH LLCIKX2025-12-06
00810178884582ViveVIVE HEALTH LLCIKX2025-12-05
00841027102441Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26
00841027102458Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26
00841027102465Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26
00841027102632Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26