POGO™ Pulsus

FDA UDI

Class I (US FDA UDI)

by DARCO International, Inc.

Identity

Trade Name: POGO™ Pulsus FDA UDI
Generic Name: Orthotic shoe, non-customized FDA UDI
Device Name: Therapeutic Shoe, Gray, Men's 4.5 / Women's 6.0 FDA UDI
Model / Reference: PGP060G FDA UDI
Description: Therapeutic Shoe, Gray, Men's 4.5 / Women's 6.0 FDA UDI

Identifiers

Catalog Number: PGP060G FDA UDI
Primary DI / UDI-DI: 00609271120501 FDA UDI
FDA Product Code: KNP FDA UDI
GMDN Term: Orthotic shoe, non-customized FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3475 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthotic shoe, non-customized

POGO™ Pulsus by DARCO International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthotic shoe, non-customized.

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DARCO® Relief Dual® Plus — Darco (Europe) GmbH · Class I
DARCO® Relief Dual® Plus — Darco (Europe) GmbH · Class I
DARCO® WCS™ — Darco (Europe) GmbH · Class I
Position Health® Classic Post-Op Shoe — Walgreen Health Solutions, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: DARCO International, Inc.

Sources (1)

FDA UDI a2c657c9-8eaf-4735-838d-6c543bdff65f 34 fields · synced Jun 9, 2026