FDA.reportPublic FDA data

Orpyx SI

Primary DI
10185571000042
Brand
Orpyx SI
Company
Orpyx
Model
ORPYXSIV1 - Start Up Kit
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
Published
2020-04-26
Public version status
Update
Distribution status
Not 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
MNEOrthosis, Moldable, Supportive, Skin Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRNDevice, Warning, Overload, External Limb, PoweredPhysical Medicine2
MNEOrthosis, Moldable, Supportive, Skin ProtectivePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18557100000045PreviousGS10
10185571000042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1855710000004518557100000045
1018557100004210185571000042

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
10185571000356Orpyx Sensory InsolesORPYXSIV1101855710003562025-02-07
10185571000066Orpyx SI Sensory InsolesOSIDDV1101855710000662025-02-07
10185571000172Orpyx Flex Sensory InsolesORPYXSIV1101855710001722025-02-07
10185571000196Orpyx Sensory InsolesWTXPOD1101855710001962025-02-07
10185571000332Orpyx Sensory InsolesORPYXSIV1101855710003322025-02-07
10185571000349Orpyx Sensory InsolesORPYXSIV1101855710003492025-02-07
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
10185571000127Orpyx SIORPYXSIV1 - Start Up Kit with Digital Display2020-04-26
10185571000509Orpyx Custom Sensory Insole SystemSI0000102025-06-19
10185571000516Orpyx Custom Sensory Insole RefillSI0000102025-06-19
10185571000554Orpyx HubOH0000102025-06-19
10185571000059Orpyx SIORPYXSIV1 - Insoles2020-04-26
18557100000045Orpyx SI sensory insolesORPYXSIV12019-12-17
11855710000019SurroSense Rx SystemSSV12016-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809818038265Guardian SupporterBM KOREA CO., LTDMNE2025-06-23
08809818038272Guardian SupporterBM KOREA CO., LTDMNE2025-06-23
08809818038289Guardian SupporterBM KOREA CO., LTDMNE2025-06-23
08809818038296Guardian SupporterBM KOREA CO., LTDMNE2025-06-23
10185571000509Orpyx Custom Sensory Insole SystemOrpyxMNE2025-06-19
10185571000509Orpyx Custom Sensory Insole SystemOrpyxIRN2025-06-19
10185571000516Orpyx Custom Sensory Insole RefillOrpyxMNE2025-06-19
10185571000516Orpyx Custom Sensory Insole RefillOrpyxIRN2025-06-19
10185571000554Orpyx HubOrpyxIRN2025-06-19
08809818037992Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038005Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038012Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038029Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038074Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038081Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038098Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038104Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
10185571000066Orpyx SI Sensory InsolesOrpyxIRN2025-02-07
10185571000172Orpyx Flex Sensory InsolesOrpyxIRN2025-02-07
10185571000196Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000332Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000332Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000349Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000349Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000356Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000356Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000363Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000363Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000400Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000417Orpyx Sensory InsolesOrpyxIRN2025-02-07