NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Foam 18x16x4x2

FDA UDI

Class I (US FDA UDI)

by N.y. Orthopedic Usa, Inc.

Identity

Trade Name: NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Foam 18x16x4x2 FDA UDI
Generic Name: Wheelchair seat cushion FDA UDI
Device Name: For patients requiring hip positioning that are inclined to slide forward, the NYOrtho APEX CORE™ Wedge Pommel Foam Cushion, combines a firm core foundation that eliminates hammocking with the superlative APEX™ innovative design. A high-performance stretch cover, improves moisture evaporation and enhances the APEX™ design features. FDA UDI
Model / Reference: 9599-WP-181642 FDA UDI
Description: For patients requiring hip positioning that are inclined to slide forward, the NYOrtho APEX CORE™ Wedge Pommel Foam Cushion, combines a firm core foundation that eliminates hammocking with the superlative APEX™ innovative design. A high-performance stretch cover, improves moisture evaporation and enhances the APEX™ design features. FDA UDI

Identifiers

Primary DI / UDI-DI: 00811677015903 FDA UDI
FDA Product Code: IMP FDA UDI
GMDN Term: Wheelchair seat cushion FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3920 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Wheelchair seat cushion

NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Foam 18x16x4x2 by N.y. Orthopedic Usa, Inc. — Class I — FDA UDI — listed in FDA GUDID

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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: N.y. Orthopedic Usa, Inc.

Sources (1)

FDA UDI 568e146c-e039-496b-b31a-2058a3e715a9 34 fields · synced Jun 8, 2026