Identity
- Trade Name
- Orpyx SI FDA UDI
- Generic Name
- Plantar pressure/morphology assessment unit FDA UDI
- Device Name
- The Orpyx® SI sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud for remote monitoring purposes. The following items are included in the ORPYXSIV1 - Insoles package: - 1 pair custom insoles - Instruction for use manual FDA UDI
- Model / Reference
- ORPYXSIV1 - Insoles FDA UDI
- Description
- The Orpyx® SI sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud for remote monitoring purposes. The following items are included in the ORPYXSIV1 - Insoles package: - 1 pair custom insoles - Instruction for use manual FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10185571000059 FDA UDI
- FDA Product Code
- IRN FDA UDIMNE FDA UDI
- GMDN Term
- Plantar pressure/morphology assessment unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5575 FDA UDI890.3475 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Orpyx SI by Orpyx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Orpyx
Sources (1)
- FDA UDI c96cdbf4-80a5-426a-bec1-92fc9ec5e2fd 34 fields · synced Jun 8, 2026