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Orpyx SI sensory insoles

FDA UDI

Class I (US FDA UDI)

by Orpyx

Identity

Trade Name
Orpyx SI sensory insoles FDA UDI
Generic Name
Plantar pressure/morphology assessment unit FDA UDI
Device Name
Orpyx SI sensory insoles are custom insoles embedded with powered limb overload warning technology intended for monitoring physiologic parameters, including plantar pressure and temperature. It provides the user with real-time, individualized cues for pressure offloading. it is intended to act as an adjunct to standard foot care, not a replacement. FDA UDI
Model / Reference
ORPYXSIV1 FDA UDI
Description
Orpyx SI sensory insoles are custom insoles embedded with powered limb overload warning technology intended for monitoring physiologic parameters, including plantar pressure and temperature. It provides the user with real-time, individualized cues for pressure offloading. it is intended to act as an adjunct to standard foot care, not a replacement. FDA UDI

Identifiers

Primary DI / UDI-DI
18557100000045 FDA UDI
FDA Product Code
MNE FDA UDI
IRN FDA UDI
GMDN Term
Plantar pressure/morphology assessment unit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 FDA UDI
890.5575 FDA UDI
Commercial Distribution
Not 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

Orpyx SI sensory insoles by Orpyx — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orpyx

Sources (1)

  • FDA UDI aec5507f-3bd2-484a-b0f4-726e5184181e 34 fields · synced May 30, 2026