AccessGUDID - DEVICE: Orpyx SI sensory insoles (18557100000045)

GUDID

Device Identifier (DI) Information

Brand Name: Orpyx SI sensory insoles
Version or Model: ORPYXSIV1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Orpyx

Primary DI Number: 18557100000045
Issuing Agency: GS1
Commercial Distribution End Date: March 09, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 250917031 *Terms of Use

Device Description: Orpyx SI sensory insoles are custom insoles embedded with powered limb overload warning technology intended for monitoring physiologic parameters, including plantar pressure and temperature. It provides the user with real-time, individualized cues for pressure offloading. it is intended to act as an adjunct to standard foot care, not a replacement.

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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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
MNE	Orthosis, Moldable, Supportive, Skin Protective
IRN	Device, Warning, Overload, External Limb, Powered

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: aec5507f-3bd2-484a-b0f4-726e5184181e
Public Version Date: November 03, 2023
Public Version Number: 3
DI Record Publish Date: December 17, 2019