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Orpyx Sensory Insoles

FDA UDI

Class I (US FDA UDI)

by Orpyx

Identity

Trade Name
Orpyx Sensory Insoles FDA UDI
Generic Name
Pressure monitoring insole FDA UDI
Device Name
The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system. The following is included: 1 pair of custom insoles - Instructions for use manual - 4 months of RPM support - 3rd party contracted scanning, fitting and dispensing support FDA UDI
Model / Reference
ORPYXSIV1 FDA UDI
Description
The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system. The following is included: 1 pair of custom insoles - Instructions for use manual - 4 months of RPM support - 3rd party contracted scanning, fitting and dispensing support FDA UDI

Identifiers

Catalog Number
10185571000493 FDA UDI
Primary DI / UDI-DI
10185571000493 FDA UDI
FDA Product Code
OIZ FDA UDI
MNE FDA UDI
IRN FDA UDI
GMDN Term
Pressure monitoring insole FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5050 FDA UDI
890.3475 FDA UDI
890.5575 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pressure monitoring insole

Orpyx Sensory Insoles by Orpyx — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pressure monitoring insole.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orpyx

Sources (1)

  • FDA UDI f54c695a-8b5b-49a2-9eef-1945cabdf9ad 34 fields · synced Jun 8, 2026