Axiom

Basic Information

• Brand Name: Axiom
• Primary DI: 00840363365916
• Version / Model: Axiom
• Catalog Number: TS14SS
• Company Name: KI MOBILITY, LLC
• Labeler DUNS: 609305656
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-02
• Public Version: 1
• Public Version Date: 2024-01-10
• Public Version Status: New
• Public Device Record Key: 3ee54565-0a2d-418a-966b-a0b697a1ad43

Device Description

Tri-Soft Headrest 14" with Std. Straight Removable Adjustable Hardware

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: Yes
• Has Serial Number: No
• 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
KNO	ACCESSORIES, WHEELCHAIR	Physical Medicine	890.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37744	Wheelchair bracket	A device, typically a metal rack, that is attached to a wheelchair and used to mount accessories for wheelchair customization or to adapt to new requirements.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840363365916	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			14"