Safari

Basic Information

• Brand Name: Safari
• Primary DI: 10840117400235
• Version / Model: SFT12
• Catalog Number: 900493
• Company Name: CONVAID PRODUCTS, INC.
• Labeler DUNS: 011245388
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-24
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: b6d4ae95-fc02-4c16-b380-0b1e4b2ed551

Device Description

Safari models are manual wheelchairs intended to provide mobility to a person with disabilities who is permanently or partially non-ambulatory and limited to a seated position.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
LBE	Stroller, Adaptive	Physical Medicine	890.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45052	Transport wheelchair, collapsible	A wheeled personal mobility device designed for transporting persons (not bariatric) over a short distance 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 simple seat-support system for a person with a disability or a person without the full capacity to walk. It will also include 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
41630	Attendant-only-propelled wheelchair, non-bariatric	A non-powered wheeled mobility device with a seat designed to enable a healthcare provider/carer to transport a non-bariatric person without the full capacity to walk, typically over short distances and over smooth ground. Often referred to as a transport wheelchair, it is typically designed with four small wheels and includes rear-fitted handles for attendant control of the chair; it does not provide the occupant a mechanism for self-propulsion (it is not a push-rim wheelchair). It provides no function outside of wheeled mobilization.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10840117400235	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K810676	000