Setmark Incorporated

Basic Information

• Brand Name: Setmark Incorporated
• Primary DI: 00854204008092
• Version / Model: WC-116
• Company Name: SETMARK INC.
• Labeler DUNS: 080798558
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 69eea1e7-63da-4aec-81f0-26e831f1a2c5

Device Description

Transport chair, stainless steel, 20" seat width -12-1/2" rear wheels, 300lb. capacity.Dark Blue,

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
IOR	Wheelchair, Mechanical	Physical Medicine	890.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57980	Bariatric transport wheelchair, collapsible	A wheeled personal mobility device designed for transporting bariatric (obese) persons over short distances and generally limited to indoor use or use outdoors over smooth paved surfaces. It has small wheels that the occupant cannot use for propulsion and incorporates a heavy-duty framework and extra wide seat-support system for an obese person with a disability or obese person without the full capacity to walk. It also includes footrests to keep the occupant's feet raised from the ground. It is typically used in hospitals, institutions, airports, and railway stations. Also known as a transportation chair or transit wheelchair, it may be disassembled or folded for transport.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854204008092	GS1

Premarket Submissions

Submission Number	Supplement Number
K973418	000