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Orpyx Sensory Insoles

FDA UDI

Class I (US FDA UDI)

by Orpyx

Identity

Trade Name
Orpyx Sensory Insoles FDA UDI
Generic Name
Pressure monitoring insole FDA UDI
Device Name
The Orpyx® Custom 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 to enable remote monitoring. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 4 months of RPM support - support for scanning, fitting and dispensing. FDA UDI
Model / Reference
ORPYXSIV1 FDA UDI
Description
The Orpyx® Custom 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 to enable remote monitoring. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 4 months of RPM support - support for scanning, fitting and dispensing. FDA UDI

Identifiers

Catalog Number
10185571000486 FDA UDI
Primary DI / UDI-DI
10185571000486 FDA UDI
FDA Product Code
MNE FDA UDI
IRN FDA UDI
OIZ FDA UDI
GMDN Term
Pressure monitoring insole FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 FDA UDI
890.5575 FDA UDI
890.5050 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

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

Category: Pressure monitoring insole

Orpyx Sensory Insoles by Orpyx — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pressure monitoring insole.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orpyx

Sources (1)

  • FDA UDI b35c1ea0-4442-425f-9ff3-9585ae0b5b19 34 fields · synced Jun 8, 2026