FDA.reportPublic FDA data

Orpyx SI Sensory Insoles

Primary DI
10185571000066
Brand
Orpyx SI Sensory Insoles
Company
Orpyx
Model
OSIDDV1
Catalog number
10185571000066
Device description
The Orpyx Sensory Insole Digital Display is part of the the Orpyx® sensory insole system. The digital display is a locked smartphone with the Orpyx Sensory Insole mobile application. The device provides the user with notification, and enables the transfer of data to enable remote patient monitoring.The following is included: 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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRNDevice, Warning, Overload, External Limb, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10185571000066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1018557100006610185571000066

GMDN Terms#

Term, Definition table
TermDefinition
Wireless patient monitor/sensor reporting software, layperson-useA software program intended to be used by a layperson at home to receive data from a noninvasive, patient-worn, wireless monitor/sensor to display, record, and assist in analysis and healthcare provider reporting of the collected clinical data, typically for continuous monitoring and optional communication with a clinician. It may enable configuration of alert notifications and is typically installed on an off-the-shelf, portable, computerized device (e.g., smartphone, tablet); it is not dedicated to bedside monitoring.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
250917031
Device count
1
Premarket exempt
true
Manufacturing date on label
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
10185571000172Orpyx Flex Sensory InsolesORPYXSIV1101855710001722025-02-07
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
10185571000509Orpyx Custom Sensory Insole SystemOrpyxIRN2025-06-19
10185571000516Orpyx Custom Sensory Insole RefillOrpyxIRN2025-06-19
10185571000554Orpyx HubOrpyxIRN2025-06-19
10185571000172Orpyx Flex Sensory InsolesOrpyxIRN2025-02-07
10185571000196Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000332Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000349Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000356Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000363Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000400Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000417Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000462Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000479Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000486Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000493Orpyx Sensory InsolesOrpyxIRN2025-02-07
10185571000042Orpyx SIOrpyxIRN2020-04-26
10185571000059Orpyx SIOrpyxIRN2020-04-26
10185571000127Orpyx SIOrpyxIRN2020-04-26
18557100000045Orpyx SI sensory insolesOrpyxIRN2019-12-17
11855710000019SurroSense Rx SystemOrpyxIRN2016-10-10