AccessGUDID - DEVICE: Orpyx SI (10185571000127)

GUDID

Device Identifier (DI) Information

Brand Name: Orpyx SI
Version or Model: ORPYXSIV1 - Start Up Kit with Digital Display
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Orpyx

Primary DI Number: 10185571000127
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 250917031 *Terms of Use

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 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 for remote monitoring purposes. The following is included in the Orpyx SI Start Up Kit with Digital Display: - 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRN	Device, Warning, Overload, External Limb, Powered
MNE	Orthosis, Moldable, Supportive, Skin Protective

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: e1d8e28f-1e94-4373-8039-ad0f8e514bc9
Public Version Date: November 03, 2023
Public Version Number: 2
DI Record Publish Date: April 26, 2020