Identity
- Trade Name
- FeetMe Monitor FTM-DK FDA UDI
- Generic Name
- Pressure monitoring insole FDA UDI
- Model / Reference
- PVT3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760349820055 FDA UDI
- FDA Product Code
- JFC FDA UDI
- GMDN Term
- Pressure monitoring insole FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.1600 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
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Pressure monitoring insole
FeetMe Monitor FTM-DK by Feetme — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- STEPRITE — MEDHAB, LLC · Class II
- Orpyx Sensory Insoles — Orpyx · Class II
- Orpyx Sensory Insoles — Orpyx · Class II
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
- Feetme
Sources (1)
- FDA UDI 4f057c9f-a00f-45e6-833e-c12739f26586 32 fields · synced May 30, 2026