Identity
- Trade Name
- Cadense FDA UDI
- Generic Name
- Orthotic shoe, non-customized FDA UDI
- Device Name
- Cadense’s Havena Slipper applies our cutting-edge Variable Friction Technology to a fur-lined, suede upper silhouette specifically designed for individuals experiencing walking difficulties. By integrating adaptive support and controlled friction into a relaxed form factor, the Havena provides safe, comfortable mobility indoors and during periods of rest. This slipper combines proven technology with functional comfort for low-impact daily use. FDA UDI
- Model / Reference
- Havena Women's R1 FDA UDI
- Description
- Cadense’s Havena Slipper applies our cutting-edge Variable Friction Technology to a fur-lined, suede upper silhouette specifically designed for individuals experiencing walking difficulties. By integrating adaptive support and controlled friction into a relaxed form factor, the Havena provides safe, comfortable mobility indoors and during periods of rest. This slipper combines proven technology with functional comfort for low-impact daily use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810195430755 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 f36525de-700c-433d-b3c5-5cb282b28f0f 34 fields · synced May 30, 2026