FDA UDI
In Commercial Distribution
🇺🇸 United States
Cadense
DI: 00810195430564
·
Model: Original Women's R3
·
Cadense, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cadense
- Primary DI
- 00810195430564
- Version / Model
- Original Women'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
- 3cbbf8fe-8dab-4bcd-a79c-9138e1ae8ab6
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 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 | 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 | 00810195430564 | GS1 |
Customer Contacts
- Phone
- 805-225-7765
- [email protected]