Identity
- Trade Name
- TFP-S Tenderfoot Pad EUDAMEDSoft Stride FDA UDI
- Generic Name
- Orthotic insole, prefabricated, non-antimicrobial FDA UDI
- Device Name
- Soft Stride™ TFP-S Tenderfoot Pad EUDAMEDTenderfoot Pad FDA UDI
- Model / Reference
- 71411 EUDAMEDFDA UDISmall EUDAMED
- Description
- Tenderfoot Pad FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821617141180 EUDAMED00082161714118 FDA UDI
- Basic UDI-DI
- 082161SOSTTFPF6 EUDAMED
- FDA Product Code
- IQI FDA UDI
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- GMDN Term
- Orthotic insole, prefabricated, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 insole, prefabricated, non-antimicrobial
Soft Stride by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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- Medisole Forefoot Women size 39 — Dumco B.V. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brownmed, Inc.
Sources (2)
- FDA UDI 7e21678f-f6fc-4ebc-9570-7f6bc017e35f 33 fields · synced Jul 21, 2026
- EUDAMED a7eb6550-ffb9-42db-a42f-04ab332e9693 61 fields · synced Jul 8, 2026