Cadense

Basic Information

• Brand Name: Cadense
• Primary DI: 00810195430588
• Version / Model: AERIO Men's R1
• Company Name: Cadense, Inc.
• Labeler DUNS: 119535700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-08
• Public Version: 1
• Public Version Date: 2025-07-16
• Public Version Status: New
• Public Device Record Key: 0710c19a-2289-4487-8d7e-918a9d9dde36

Device Description

Cadense AERIOs are adaptive sandal-slide hybrids designed to help with walking difficulties in a warm-weather format. Built with the same Variable Friction Technology as the Cadense Originals, they support smoother movement and greater ease on multiple surfaces. AERIOs feature a removable backstrap, adjustable front closure, and a supportive sole engineered for daily comfort. This versatile style offers an accessible option for those seeking adaptable footwear without compromising on functionality or design.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: 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
KNP	Orthosis, Corrective Shoe	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31041	Orthotic shoe, non-customized	A prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810195430588	GS1

Customer Contacts

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