FDA.report

Invisia™ Corner Seat (Oil Rubbed Bronze, Walnut Stain)

Primary DI
00689281031226
Brand
Invisia™ Corner Seat (Oil Rubbed Bronze, Walnut Stain)
Company
Healthcraft Products Inc.
Model
INV-WSCS-WNT-ORB
Catalog number
03122
Device description
The Invisia Corner Seat is a high quality, commercial grade shower seat. The Invisia Corner Seat is intended to provide shower seating support for people with reduced mobility. The Invisia Corner 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

Related Records

Product Codes

CodeName
IKXAid, Transfer

Product Code Classifications

CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00689281031226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00689281031226006892810312266892810312260689281031226

GMDN Terms

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

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

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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

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