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Orpyx Sensory Insoles

FDA UDI

Class II (US FDA UDI)

by Orpyx

Identity

Trade Name
Orpyx Sensory Insoles FDA UDI
Generic Name
Pressure monitoring insole FDA UDI
Device Name
Orpyx Flex Sensory Insoles refill (1 pair) - This is a set of pre-fabricated sensory insoles compatible with the Orpyx Sensory Insole system. Included in the package: pre-fabricated sensory insoles - instructions for use manual FDA UDI
Model / Reference
ORPYXSIV1 FDA UDI
Description
Orpyx Flex Sensory Insoles refill (1 pair) - This is a set of pre-fabricated sensory insoles compatible with the Orpyx Sensory Insole system. Included in the package: pre-fabricated sensory insoles - instructions for use manual FDA UDI

Identifiers

Catalog Number
10185571000400 FDA UDI
Primary DI / UDI-DI
10185571000400 FDA UDI
FDA Product Code
IRN FDA UDI
OIZ FDA UDI
GMDN Term
Pressure monitoring insole FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5575 FDA UDI
890.5050 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 II — 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 b41faa9c-0ae5-4580-9dcc-272317d6cdd3 34 fields · synced Jun 6, 2026