FDA.report

Nxt

Primary DI
00814462000146
Brand
Nxt
Company
1422791 Ontario Ltd
Model
Optima carbon deep
Device description
SUPPORT, HEAD AND TRUNK, WHEELCHAIR
Published
2022-10-28
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

Related Records

Contact Domains

Product Codes

CodeName
IMSSupport, Head And Trunk, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
IMSSupport, Head And Trunk, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00814462000146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00814462000146008144620001468144620001460814462000146

GMDN Terms

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

Contacts

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

Regulatory Flags

DUNS number
202694761
Device count
1
DM exempt
true
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 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
00814462000153NxtArmadillo2022-10-28
00814462000160NxtBiofit2022-10-28
00814462000177NxtNufit2022-10-28

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