FDA.reportPublic FDA data

Nxt

Primary DI
00814462000160
Brand
Nxt
Company
1422791 Ontario Ltd
Model
Biofit
Device description
CUSHION, WHEELCHAIR
Published
2022-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00814462000160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814462000160008144620001608144620001600814462000160

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
1-866-875-2877info@dynamichcs.com

Regulatory Flags#

DUNS number
202694761
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814462000016NxtXtend2022-10-28
00814462000023NxtXtend deep2022-10-28
00814462000030NxtXtend low2022-10-28
00814462000047NxtXtend low deep2022-10-28
00814462000054NxtClassic2022-10-28
00814462000061NxtClassic deep2022-10-28
00814462000115NxtOptima2022-10-28
00814462000122NxtOptima deep2022-10-28
00814462000139NxtOptima carbon2022-10-28
00814462000146NxtOptima carbon deep2022-10-28
00814462000153NxtArmadillo2022-10-28
00814462000177NxtNufit2022-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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