FDA.reportPublic FDA data

Nxt

Primary DI
00814462000061
Brand
Nxt
Company
1422791 Ontario Ltd
Model
Classic deep
Device description
SUPPORT, HEAD AND TRUNK, WHEELCHAIR
Published
2022-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMSSupport, Head And Trunk, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMSSupport, Head And Trunk, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814462000061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814462000061008144620000618144620000610814462000061

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair head/trunk support, prefabricatedA prefabricated (non-customized) padded and contoured device designed to attach to the back/seat of a wheelchair to provide the wheelchair occupant with head and trunk postural support and comfort. 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
00814462000115NxtOptima2022-10-28
00814462000122NxtOptima deep2022-10-28
00814462000139NxtOptima carbon2022-10-28
00814462000146NxtOptima carbon deep2022-10-28
00814462000153NxtArmadillo2022-10-28
00814462000160NxtBiofit2022-10-28
00814462000177NxtNufit2022-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540147004033Side Mount Headrest Interface PlateMotion Concepts IncIMS2026-05-19
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10194484321960CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321977CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321984CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321991CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322004CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322011CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322028CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322035CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322042CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
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10194484322073CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
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10194484322240CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322257CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22