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Orpyx SI

FDA UDI

Class II (US FDA UDI)

by Orpyx

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 (pair) which wirelessly communicates with a display application running on a smartphone. 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 is included in the the Orpyx SI Start Up Kit - 1 pair of custom insoles - Charging accessories (cable and wall adapter - Instructions for use manual FDA UDI
Model / Reference
ORPYXSIV1 - Start Up Kit 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 (pair) which wirelessly communicates with a display application running on a smartphone. 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 is included in the the Orpyx SI Start Up Kit - 1 pair of custom insoles - Charging accessories (cable and wall adapter - Instructions for use manual FDA UDI

Identifiers

Primary DI / UDI-DI
10185571000042 FDA UDI
FDA Product Code
IRN FDA UDI
MNE FDA UDI
GMDN Term
Plantar pressure/morphology assessment unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5575 FDA UDI
890.3475 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

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Manufacturer

Manufacturer
Orpyx

Sources (1)

  • FDA UDI 34433e54-e9bb-48ec-87f8-8291935d4c59 34 fields · synced May 29, 2026