FDA.reportPublic FDA data

Orpyx Flex Sensory Insoles

Primary DI
10185571000172
Brand
Orpyx Flex Sensory Insoles
Company
Orpyx
Model
ORPYXSIV1
Catalog number
10185571000172
Device description
The Orpyx® Flex Sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into pre-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 in the Orpyx Flex Sensory Insoles Start Up Kit: - 1 pair of flex insoles - Digital Display - Charging accessories - Instructions for use manual
Published
2025-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IRNDevice, Warning, Overload, External Limb, Powered
OIZFoot Examination Tool For Inflammatory Changes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRNDevice, Warning, Overload, External Limb, PoweredPhysical Medicine2
OIZFoot Examination Tool For Inflammatory ChangesPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10185571000172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1018557100017210185571000172

GMDN Terms#

Term, Definition table
TermDefinition
Pressure monitoring insoleA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
250917031
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10185571000509Orpyx Custom Sensory Insole SystemSI0000102025-06-19
10185571000516Orpyx Custom Sensory Insole RefillSI0000102025-06-19
10185571000554Orpyx HubOH0000102025-06-19
10185571000066Orpyx SI Sensory InsolesOSIDDV1101855710000662025-02-07
10185571000196Orpyx Sensory InsolesWTXPOD1101855710001962025-02-07
10185571000332Orpyx Sensory InsolesORPYXSIV1101855710003322025-02-07
10185571000349Orpyx Sensory InsolesORPYXSIV1101855710003492025-02-07
10185571000356Orpyx Sensory InsolesORPYXSIV1101855710003562025-02-07
10185571000363Orpyx Sensory InsolesORPYXSIV1101855710003632025-02-07
10185571000400Orpyx Sensory InsolesORPYXSIV1101855710004002025-02-07
10185571000417Orpyx Sensory InsolesORPYXSIV1101855710004172025-02-07
10185571000462Orpyx Sensory InsolesORPYXSIV1101855710004622025-02-07
10185571000479Orpyx Sensory InsolesORPYXSIV1101855710004792025-02-07
10185571000486Orpyx Sensory InsolesORPYXSIV1101855710004862025-02-07
10185571000493Orpyx Sensory InsolesORPYXSIV1101855710004932025-02-07
10185571000042Orpyx SIORPYXSIV1 - Start Up Kit2020-04-26
10185571000059Orpyx SIORPYXSIV1 - Insoles2020-04-26
10185571000127Orpyx SIORPYXSIV1 - Start Up Kit with Digital Display2020-04-26
18557100000045Orpyx SI sensory insolesORPYXSIV12019-12-17
11855710000019SurroSense Rx SystemSSV12016-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00866538000338Podimetrics SmartMat+Podimetrics, Inc.OIZ2025-12-30
00860013816506Empo FootprintEmpo Health, Inc.OIZ2025-07-31
10185571000509Orpyx Custom Sensory Insole SystemOrpyxIRN2025-06-19
10185571000516Orpyx Custom Sensory Insole RefillOrpyxIRN2025-06-19
10185571000554Orpyx HubOrpyxIRN2025-06-19
10185571000066Orpyx SI Sensory InsolesOrpyxIRN2025-02-07
10185571000196Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000332Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000332Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000349Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000349Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000356Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000356Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000363Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000363Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000400Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000400Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000417Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000417Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000462Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000462Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000479Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000479Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000486Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000486Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000493Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000493Orpyx Sensory InsolesOrpyxOIZ2025-02-07
00866538000321Podimetrics Wi-Fi SmartMatPodimetrics, Inc.OIZ2024-04-06
05391536710002Bluedrop MedicalBLUEDROP MEDICAL LIMITEDOIZ2023-09-18
00866538000307Podimetrics SmartMatPodimetrics, Inc.OIZ2021-09-07