Folding Shower Seat

Basic Information

• Brand Name: Folding Shower Seat
• Primary DI: 00689281035262
• Version / Model: FDS-S
• Catalog Number: 03526
• Company Name: Healthcraft Products Inc.
• Labeler DUNS: 252468293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-31
• Public Version: 1
• Public Version Date: 2022-02-08
• Public Version Status: New
• Public Device Record Key: e777ab69-f6ad-4b66-b491-7b61b1bf1210

Device Description

The Fold Down Seat is a high quality, commercial grade, fold down shower seat. The Fold Down Seat is intended to provide shower seating support for people with reduced mobility. The Fold Down 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 Fold Down Seat is intended to be folded up when not in use. The hinge allows the seat to open slowly, and lock against the wall in the folded position. The Fold Down Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 440lbs / 200kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Fold Down Seat is not to be used in any other way than described above.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKX	Aid, Transfer	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34936	Shower seat, non-powered	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00689281035262	GS1
Package	10689281035269	GS1	CARTON	5	In Commercial Distribution