Orpyx Flex Sensory Insoles 10185571000172

GUDID 10185571000172

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

Orpyx

Pressure monitoring insole
Primary Device ID10185571000172
NIH Device Record Keyf2c41564-8608-4fc2-815c-479a9f00b7a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrpyx Flex Sensory Insoles
Version Model NumberORPYXSIV1
Catalog Number10185571000172
Company DUNS250917031
Company NameOrpyx
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110185571000172 [Primary]

FDA Product Code

IRNDevice, Warning, Overload, External Limb, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-17
Device Publish Date2025-02-07

Devices Manufactured by Orpyx

10185571000066 - Orpyx SI Sensory Insoles2025-02-17 The Orpyx Sensory Insole Digital Display is part of the the Orpyx® sensory insole system. The digital display is a locked smart
10185571000172 - Orpyx Flex Sensory Insoles2025-02-17The 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
10185571000172 - Orpyx Flex Sensory Insoles2025-02-17 The Orpyx® Flex Sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure
10185571000196 - Orpyx Sensory Insoles2025-02-17 Orpyx Sensory Insoles wireless charger and wall adapter replacement which is part of Orpyx Sensory Insole system. The charger en
10185571000332 - Orpyx Sensory Insoles2025-02-17 The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressur
10185571000349 - Orpyx Sensory Insoles2025-02-17 The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressur
10185571000356 - Orpyx Sensory Insoles2025-02-17 The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support
10185571000363 - Orpyx Sensory Insoles2025-02-17 Orpyx Custom Sensory Insoles refill (1 pair) - This is a set of custom sensory insoles compatible with the Orpyx Sensory Insole
10185571000400 - Orpyx Sensory Insoles2025-02-17 Orpyx Flex Sensory Insoles refill (1 pair) - This is a set of pre-fabricated sensory insoles compatible with the Orpyx Sensory I
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