Identity
- Trade Name
- Cadense FDA UDI
- Generic Name
- Orthotic shoe, non-customized FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Original Men's R3 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810195430557 FDA UDI
- FDA Product Code
- KNP FDA UDI
- GMDN Term
- Orthotic shoe, non-customized FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthotic shoe, non-customized
Cadense by Cadense Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cadense Inc
Sources (1)
- FDA UDI c788ab13-8618-44fd-adb1-b6049632b632 34 fields · synced May 30, 2026