FDA UDI
In Commercial Distribution
🇺🇸 United States
Cadense
DI: 00810195430755
·
Model: Havena Women's R1
·
Cadense, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cadense
- Primary DI
- 00810195430755
- Version / Model
- Havena Women's R1
- Company Name
- Cadense, Inc.
- Labeler DUNS
- 119535700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-18
- Public Version
- 1
- Public Version Date
- 2025-08-26
- Public Version Status
- New
- Public Device Record Key
- f36525de-700c-433d-b3c5-5cb282b28f0f
Device 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.
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 | 00810195430755 | GS1 |
Customer Contacts
- Phone
- 805-225-7765
- [email protected]