AccessGUDID - DEVICE: Orpyx Sensory Insoles (10185571000417)

GUDID

Device Identifier (DI) Information

Brand Name: Orpyx Sensory Insoles
Version or Model: ORPYXSIV1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10185571000417
Company Name: Orpyx

Primary DI Number: 10185571000417
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 250917031 *Terms of Use

Device 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61782	Pressure monitoring insole	A battery-powered device intended to be worn against the sole of the foot to sense, measure, and transmit information regarding plantar pressure distribution for the biomechanical analysis of gait. It is typically a synthetic insole with integrated pressure sensors and a wireless transmitter, whereby pressure distribution data is intended to be transmitted to, and analysed with, an off-the-shelf tablet/smartphone/computer containing dedicated software; a battery charger may be included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRN	Device, Warning, Overload, External Limb, Powered
MNE	Orthosis, Moldable, Supportive, Skin Protective
OIZ	Foot Examination Tool For Inflammatory Changes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b31365ff-a1b3-4993-b650-a5e873d40422
Public Version Date: February 17, 2025
Public Version Number: 1
DI Record Publish Date: February 07, 2025