Softzone All Gel Met Pad with Toe Spreader, Large/XLarge, 1pair/box
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Softzone All Gel Met Pad with Toe Spreader, Large/XLarge, 1pair/box FDA UDI
- Generic Name
- Foot friction/impact protector FDA UDI
- Model / Reference
- 4021 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00614464040214 FDA UDI
- FDA Product Code
- KYS FDA UDI
- GMDN Term
- Foot friction/impact protector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6280 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Foot friction/impact protector
The Softzone All Gel Met Pad with Toe Spreader, Large/XLarge, 1pair/box is a high-quality insole designed to provide comfort and support for individuals experiencing foot friction or impact while walking. Made from soft-padded gel materials, this device is perfect for those looking for a non-invasive solution to alleviate pain and prevent callouses.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- SILIPOS Holding LLC
Sources (1)
- FDA UDI 02ae5c8f-b5cc-4576-a391-66cf4407b445 32 fields · synced Jul 21, 2026