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Orpyx Hub

FDA UDI

Class II (US FDA UDI)

by Orpyx

Identity

Trade Name
Orpyx Hub FDA UDI
Generic Name
Medical networking interface unit FDA UDI
Device Name
The Orpyx Hub is the bluetooth-cellular bridge that enables sensor data from the insole to be sent to the cloud as part of the Orpyx Customer Sensory Insole System. This package contains a replacement Orpyx Hub and product documentation such as a manual. The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression. The Orpyx Custom Sensory Insole system is intended to act as an adjunct to standard footcare, not a replacement. It is designed for use throughout everyday activities. Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices. FDA UDI
Model / Reference
OH000010 FDA UDI
Description
The Orpyx Hub is the bluetooth-cellular bridge that enables sensor data from the insole to be sent to the cloud as part of the Orpyx Customer Sensory Insole System. This package contains a replacement Orpyx Hub and product documentation such as a manual. The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression. The Orpyx Custom Sensory Insole system is intended to act as an adjunct to standard footcare, not a replacement. It is designed for use throughout everyday activities. Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices. FDA UDI

Identifiers

Primary DI / UDI-DI
10185571000554 FDA UDI
FDA Product Code
IRN FDA UDI
GMDN Term
Medical networking interface unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5575 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

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

Category: Medical networking interface unit

Orpyx Hub by Orpyx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical networking interface unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orpyx

Sources (1)

  • FDA UDI 2657b4b4-ade5-4883-b353-87d8616f9d3c 33 fields · synced May 31, 2026