NYOrtho Wheelchair Cushion Gel-Foam 30x20x4

GUDID 00811677013695

NYOrtho Gel-Foam Cushions combine a dual chambered gel insert within a dual density foam body. This combination helps prevent pressure injuries, improve patient comfort and correct patient positioning. Features a high-performance stretch cover that improves moisture evaporation with an aggressive non-slip bottom keeping the cushion firmly in place.

N.Y. ORTHOPEDIC USA, INC.

Wheelchair seat cushion
Primary Device ID00811677013695
NIH Device Record Keye7f4f6c1-dbbf-45fb-894f-ef743550fcca
Commercial Distribution StatusIn Commercial Distribution
Brand NameNYOrtho Wheelchair Cushion Gel-Foam 30x20x4
Version Model Number9595-GEL-302004
Company DUNS612083873
Company NameN.Y. ORTHOPEDIC USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com
Phone718-852-5330
Emailgudid@nyorthousa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811677013695 [Primary]

FDA Product Code

IMPCushion, Wheelchair

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-11
Device Publish Date2023-09-03

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

00810114602911 - NYOrtho Wheelchair Cushion Foam 16x16x42023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
00811677011998 - NYOrtho Wheelchair Cushion Foam 18x16x42023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
00811677012025 - NYOrtho Wheelchair Cushion Foam 18x16x22023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
00811677012063 - NYOrtho Wheelchair Cushion Foam 18x16x32023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
00811677017495 - NYOrtho Wheelchair Cushion Foam 16x16x32023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
00811677017525 - NYOrtho Wheelchair Cushion Foam 18x18x22023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
00811677019611 - NYOrtho Wheelchair Cushion Foam 16x18x22023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe
00811677019628 - NYOrtho Wheelchair Cushion Foam 16x18x32023-10-13 The NYOrtho Foam Wheelchair Cushions help prevent pressure injuries, improve patient comfort and correct patient positioning. Fe

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