NYOrtho APEX CORE Pommel Wheelchair Cushion Gel-Foam 18x16x2

GUDID 00811677013602

For patients requiring hip positioning, the NYOrtho APEX CORE™ Pommel Gel-Foam Cushion, combines a firm core foundation that eliminates hammocking with the superlative APEX™ innovative design that chambers the gel-pod closer to the top of the cushion providing a cooler interface between the patient and wheelchair. A high-performance stretch cover, improves moisture evaporation and enhances the APEX™ design features.

N.Y. ORTHOPEDIC USA, INC.

Wheelchair seat cushion

• Primary Device ID: 00811677013602
• NIH Device Record Key: b869eaa4-db40-4e7e-a22f-4cf5c8c6ddaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NYOrtho APEX CORE Pommel Wheelchair Cushion Gel-Foam 18x16x2
• Version Model Number: 9599-GP-181602
• Company DUNS: 612083873
• Company Name: N.Y. ORTHOPEDIC USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com
• Phone: 718-852-5330
• Email: gudid@nyorthousa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811677013602 [Primary]

FDA Product Code

• IMP: Cushion, Wheelchair

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-09
• Device Publish Date: 2023-08-01

Devices Manufactured by N.Y. ORTHOPEDIC USA, INC.

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• 00811677011998 - NYOrtho Wheelchair Cushion Foam 18x16x4: 2023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
• 00811677012025 - NYOrtho Wheelchair Cushion Foam 18x16x2: 2023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
• 00811677012063 - NYOrtho Wheelchair Cushion Foam 18x16x3: 2023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
• 00811677017495 - NYOrtho Wheelchair Cushion Foam 16x16x3: 2023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
• 00811677017525 - NYOrtho Wheelchair Cushion Foam 18x18x2: 2023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
• 00811677019611 - NYOrtho Wheelchair Cushion Foam 16x18x2: 2023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
• 00811677019628 - NYOrtho Wheelchair Cushion Foam 16x18x3: 2023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe