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Orpyx Custom Sensory Insole Refill

FDA UDI

Class II (US FDA UDI)

by Orpyx

Identity

Trade Name
Orpyx Custom Sensory Insole Refill FDA UDI
Generic Name
Pressure monitoring insole FDA UDI
Device Name
Orpyx Custom Sensory Insole refill is includes the a replacement set of insoles for the Orpyx Custom Sensory Insole system. This package contains only the insoles and product documentation such as an Instruction for Use 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
SI000010 FDA UDI
Description
Orpyx Custom Sensory Insole refill is includes the a replacement set of insoles for the Orpyx Custom Sensory Insole system. This package contains only the insoles and product documentation such as an Instruction for Use 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
10185571000516 FDA UDI
FDA Product Code
IRN FDA UDI
MNE FDA UDI
GMDN Term
Pressure monitoring insole FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5575 FDA UDI
890.3475 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: Pressure monitoring insole

Orpyx Custom Sensory Insole Refill by Orpyx — Class II — 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 e333e76b-fad6-4598-90e8-fef761a79a8d 33 fields · synced Jun 8, 2026