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N.Y. ORTHOPEDIC USA, INC.

US

Last updated May 24, 2026

What N.Y. ORTHOPEDIC USA, INC. makes

The company produces gel-foam and foam wheelchair seat cushions in various sizes, designed to provide pressure relief and support for users. It also manufactures reusable limb/torso restraints, including padded mitts and adjustable seat belts, intended to secure residents in wheelchairs. Some cushions feature integrated pommels or coccyx supports to enhance stability and comfort.

All listed devices fall under Class I regulatory classification in the U.S., meaning they are subject to general controls without additional premarket review requirements. The products are registered in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
—
Website
nyorthousa.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
718-852-5330
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
612083873

Catalogue (137)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
NYOrtho Resident Release Cushion Belts 9704
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 26x20x3 9595-GEL-262003
FDA UDI
Class IActive
NYOrtho APEX CORE Pommel Wheelchair Cushion Gel-Foam 18x18x3 9599-GP-181803
FDA UDI
Class IActive
NYOrtho Padded Mitts 9370
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 26x20x4 9595-GEL-262004
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 16x16x3 9595-GEL-161603
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 20x18x4 9595-GEL-201804
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 24x18x2 9595-GEL-241802
FDA UDI
Class IActive
NYOrtho SureChek Wheelchair Cushion Foam 16x16x3 93-95-161603
FDA UDI
Class IActive
NYOrtho APEX CORE Wheelchair Cushion Gel-Foam 24x16x3 9599-G-241603
FDA UDI
Class IActive
NYOrtho APEX CORE Coccyx Pommel Wheelchair Cushion Gel-Foam 16x16x3 9599-GCP-161603
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 14x16x2 9595-GEL-141602
FDA UDI
Class IActive
NYOrtho APEX CORE Pommel Wheelchair Cushion Foam 16x16x2 9599-P-161602
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Foam 18x18x2 9595-181802
FDA UDI
Class IActive
NYOrtho APEX CORE Wedge Wheelchair Cushion Gel-Foam 26x20x4x2 9599-GW-262042
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 18x16x1.5 9595-GEL-18161H
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 20x18x2 9595-GEL-201802
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 22x16x2 9595-GEL-221602
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 18x18x2 9595-GEL-181802
FDA UDI
Class IActive
NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Gel-Foam 18x16x4x2 9599-GWP-181642
FDA UDI
Class IActive
NYOrtho APEX CORE Coccyx Wheelchair Cushion Gel-Foam 16x16x3 9599-GC-161603
FDA UDI
Class IActive
NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Foam 16x18x4x2 9599-WP-161842
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Foam 16x18x3 9595-161803
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 28x18x3 9595-GEL-281803
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 20x16x3 9595-GEL-201603
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Foam 16x16x4 9595-161604
FDA UDI
Class IActive
NYOrtho APEX CORE Wheelchair Cushion Gel-Foam 22x20x3 9599-G-222003
FDA UDI
Class IActive
NYOrtho APEX Wheelchair Cushion Gel-Foam 18x16x3 9597-GEL-181603
FDA UDI
Class IActive
NYOrtho APEX CORE Coccyx Pommel Wheelchair Cushion Gel-Foam 24x18x3 9599-GCP-241803
FDA UDI
Class IActive
NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Gel-Foam 22x18x4x2 9599-GWP-221842
FDA UDI
Class IActive
NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Gel-Foam 20x18x4x2 9599-GWP-201842
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 30x20x3 9595-GEL-302003
FDA UDI
Class IActive
NYOrtho APEX CORE Wheelchair Cushion Gel-Foam 20x16x3 9599-G-201603
FDA UDI
Class IActive
NYOrtho APEX CORE Coccyx Wheelchair Cushion Gel-Foam 22x16x3 9599-GC-221603
FDA UDI
Class IActive
NYOrtho APEX CORE Wedge Wheelchair Cushion Gel-Foam 18x16x4x2 9599-GW-181642
FDA UDI
Class IActive
NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Foam 18x16x4x2 9599-WP-181642
FDA UDI
Class IActive
NYOrtho APEX CORE Coccyx Pommel Wheelchair Cushion Gel-Foam 20x18x3 9599-GCP-201803
FDA UDI
Class IActive
NYOrtho APEX CORE Wedge Wheelchair Cushion Gel-Foam 24x18x4x2 9599-GW-241842
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 20x17x3 9595-GEL-201703
FDA UDI
Class IActive
NYOrtho APEX CORE Coccyx Wheelchair Cushion Gel-Foam 20x18x3 9599-GC-201803
FDA UDI
Class IActive
NYOrtho APEX CORE Wheelchair Cushion Gel-Foam 28x18x3 9599-G-281803
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 24x18x3 9595-GEL-241803
FDA UDI
Class IActive
NYOrtho APEX CORE Wheelchair Cushion Gel-Foam 26x18x3 9599-G-261803
FDA UDI
Class IActive
NYOrtho APEX CORE Coccyx Pommel Wheelchair Cushion Gel-Foam 22x18x3 9599-GCP-221803
FDA UDI
Class IActive
NYOrtho SureChek Wheelchair Cushion Foam 18x16x2 93-95-181602
FDA UDI
Class IActive
NYOrtho APEX CORE Pommel Wheelchair Cushion Gel-Foam 22x16x3 9599-GP-221603
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 20x16x2 9595-GEL-201602
FDA UDI
Class IActive
NYOrtho APEX CORE Coccyx Wheelchair Cushion Gel-Foam 18x18x3 9599-GC-181803
FDA UDI
Class IActive
NYOrtho APEX CORE Wheelchair Cushion Gel-Foam 20x18x3 9599-G-201803
FDA UDI
Class IActive
NYOrtho Wheelchair Cushion Gel-Foam 18x16x2 9595-GEL-181602
FDA UDI
Class IActive

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