E2 Carbon Fiber Fixed Hardware

Basic Information

• Brand Name: E2 Carbon Fiber Fixed Hardware
• Primary DI: 07540147001339
• Version / Model: CFFX
• Catalog Number: CFFX
• Company Name: Motion Concepts Inc
• Labeler DUNS: 259777209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 1
• Public Version Date: 2022-12-20
• Public Version Status: New
• Public Device Record Key: 359d25c2-aa52-496e-81d1-2eb04127799b

Device Description

E2 Carbon Fiber Fixed Mounting Hardware (set). Fixed mounting hardware option for Matrx E2 Carbon Fiber Backs (16H or less). Requires tools to remove. (Fits 3/4", 7/8" or 1" back cane diameters)

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: 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
KNN	Components, Wheelchair	Physical Medicine	890.3920	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64619	Wheelchair back rest positioner	A bracket-like device intended to be attached to the back canes of a wheelchair to accept the wheelchair back rest (not included) and allow for the adjustment of the back rest position (e.g., angle, depth, height). It is typically in the form of a clamp with hooks of adjustable position/orientation; pins intended to secure positioning may also be included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540147001339	GS1

Customer Contacts

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