Orpyx SI

Basic Information

• Brand Name: Orpyx SI
• Primary DI: 10185571000042
• Version / Model: ORPYXSIV1 - Start Up Kit
• Company Name: Orpyx
• Labeler DUNS: 250917031
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-26
• Public Version: 3
• Public Version Date: 2025-02-06
• Public Version Status: Update
• Public Device Record Key: 34433e54-e9bb-48ec-87f8-8291935d4c59
• Distribution End Date: 2025-01-10

Device 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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IRN	Device, Warning, Overload, External Limb, Powered	Physical Medicine	890.5575	2
MNE	Orthosis, Moldable, Supportive, Skin Protective	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62788	Plantar pressure/morphology assessment unit	An electronic device intended to detect plantar pressure distribution and/or morphology to help assess abnormal pressure and/or structural deformities (e.g., flat foot, valgus toe) on the soles of the feet. It is a freestanding platform upon which the patient’s feet are placed and evaluated by either optical-based technology (e.g., photometric imaging, 3-D camera) or pressure resistive sensors; captured data is transmitted to an off-the-shelf tablet/computer for recording, display and analysis, sometimes with dedicated software. The device is often used to help design therapeutic footwear such as orthotic shoes and insoles.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10185571000042	GS1
Previous	18557100000045	GS1