FDA UDI In Commercial Distribution 🇺🇸 United States

Cadense

DI: 00810195430557 · Model: Original Men's R3 · Cadense, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Cadense
Primary DI
00810195430557
Version / Model
Original Men's R3
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
c788ab13-8618-44fd-adb1-b6049632b632

Device Description

Cadense Originals are adaptive walking shoes specifically designed to help with walking difficulties. They feature patented Variable Friction Technology that allows the foot to glide during the swing phase and grip during toe-off, supporting smoother, more confident movement. The lightweight design, wide opening, and velcro closure make them easy to put on and wear throughout the day. Cadense Originals combine thoughtful design and function to support everyday mobility across a variety of indoor and outdoor surfaces.

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
KNP Orthosis, Corrective Shoe

GMDN Terms

Code Name
31041 Orthotic shoe, non-customized

Identifiers

Type ID
Primary 00810195430557

Customer Contacts

Phone
805-225-7765