FDA.reportPublic FDA data

SurroSense Rx System

Primary DI
11855710000019
Brand
SurroSense Rx System
Company
Orpyx
Model
SSV1
Device description
The SurroSense Rx system is a tool to help actively prevent the complications associated with peripheral neuropathy and track user progress. The system is comprised of sensor embedded inserts that are worn inside of running or walking shoes which communicate wirelessly to the Smartwatch. When dangerous time and pressure levels have been exceeded underfoot, an alerts is triggered on the Smartwatch. Subsequently, the user is to modify their behavior following offloading instructions provided on the Smartwatch.
Published
2016-10-10
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
11855710000019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1185571000001911855710000019

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

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
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

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
10185571000066Orpyx SI Sensory InsolesOrpyxIRN2025-02-07
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