FDA.reportPublic FDA data

Orpyx Sensory Insoles

Primary DI
10185571000349
Brand
Orpyx Sensory Insoles
Company
Orpyx
Model
ORPYXSIV1
Catalog number
10185571000349
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 for remote monitoring purposes. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 6 months of RPM support
Published
2025-02-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IRNDevice, Warning, Overload, External Limb, Powered
MNEOrthosis, Moldable, Supportive, Skin Protective
OIZFoot Examination Tool For Inflammatory Changes

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10185571000349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1018557100034910185571000349

Regulatory Flags#

DUNS number
250917031
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
10185571000042Orpyx SIORPYXSIV1 - Start Up Kit2020-04-26
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
00866538000338Podimetrics SmartMat+Podimetrics, Inc.OIZ2025-12-30
00860013816506Empo FootprintEmpo Health, Inc.OIZ2025-07-31
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 SystemOrpyxIRN2025-06-19
10185571000509Orpyx Custom Sensory Insole SystemOrpyxMNE2025-06-19
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
10185571000172Orpyx Flex Sensory InsolesOrpyxOIZ2025-02-07
10185571000196Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000332Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000332Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000332Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000356Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000356Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000356Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000363Orpyx Sensory InsolesOrpyxMNE2025-02-07