FDA.reportPublic FDA data

NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Gel-Foam 22x18x4x2

Primary DI
00811677018829
Brand
NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Gel-Foam 22x18x4x2
Company
N.Y. ORTHOPEDIC USA, INC.
Model
9599-GWP-221842
Device description
For patients requiring hip positioning that are inclined to slide forward, the NYOrtho APEX CORE™ Wedge 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.
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMPCushion, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811677018829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811677018829008116770188298116770188290811677018829

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair seat cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
718-852-5330gudid@nyorthousa.com

Regulatory Flags#

DUNS number
612083873
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810114602911NYOrtho Wheelchair Cushion Foam 16x16x49595-1616042023-10-05
00811677011998NYOrtho Wheelchair Cushion Foam 18x16x49595-1816042023-10-05
00811677012025NYOrtho Wheelchair Cushion Foam 18x16x29595-1816022023-10-05
00811677012063NYOrtho Wheelchair Cushion Foam 18x16x39595-1816032023-10-05
00811677017495NYOrtho Wheelchair Cushion Foam 16x16x39595-1616032023-10-05
00811677017525NYOrtho Wheelchair Cushion Foam 18x18x29595-1818022023-10-05
00811677019611NYOrtho Wheelchair Cushion Foam 16x18x29595-1618022023-10-05
00811677019628NYOrtho Wheelchair Cushion Foam 16x18x39595-1618032023-10-05
00810114600245NYOrtho Wheelchair Cushion Gel-Foam 20x20x29595-GEL-2020022023-09-03
00810114600252NYOrtho Wheelchair Cushion Gel-Foam 22x20x29595-GEL-2220022023-09-03
00810114600269NYOrtho Wheelchair Cushion Gel-Foam 22x22x29595-GEL-2222022023-09-03
00810114600276NYOrtho Wheelchair Cushion Gel-Foam 22x22x39595-GEL-2222032023-09-03
00810114600283NYOrtho Wheelchair Cushion Gel-Foam 26x18x29595-GEL-2618022023-09-03
00810114600290NYOrtho Wheelchair Cushion Gel-Foam 28x18x29595-GEL-2818022023-09-03
00810114600306NYOrtho Wheelchair Cushion Gel-Foam 30x18x39595-GEL-3018032023-09-03
00810114601648NYOrtho Wheelchair Cushion Gel-Foam 34x20x49595-GEL-3420042023-09-03
00811677011868NYOrtho Wheelchair Cushion Foam 16x16x29595-1616022023-09-03
00811677012001NYOrtho Wheelchair Cushion Gel-Foam 18x18x39595-GEL-1818032023-09-03
00811677012032NYOrtho Wheelchair Cushion Gel-Foam 20x16x39595-GEL-2016032023-09-03
00811677012049NYOrtho Wheelchair Cushion Gel-Foam 22x18x29595-GEL-2218022023-09-03

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