FDA.reportPublic FDA data

Spex

Primary DI
09420051708747
Brand
Spex
Company
SPEX LIMITED
Model
1156-5823-410
Device description
Spex Comfi Arm Support Pad Size 3Wide 90mm x 350mm, with removable cover
Published
2023-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMYArmboard, Wheelchair
KNNComponents, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMYArmboard, WheelchairPhysical Medicine1
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420051708747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420051708747094200517087479420051708747

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair armrestA small platform, typically cushioned, mounted on the lateral ends of a wheelchair to provide the user with a support on which to place the arms. The position of the platform (e.g., height) may be adjustable to suit the comfort and utility of the user.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
748649195
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09420082931091Spex Limited1256-1012-0SS-W2026-07-31
09420082931107Spex Limited1256-1014-0SS-W2026-07-31
09420082931114Spex Limited1256-1016-0SS-W2026-07-31
09420082931121Spex Limited1256-1112-0SS-W2026-07-31
09420082931138Spex Limited1256-1114-0SS-W2026-07-31
09420082931145Spex Limited1256-1116-0SS-W2026-07-31
09420082931152Spex Limited1256-1212-0SS-W2026-07-31
09420082931169Spex Limited1256-1214-0SS-W1256-1214-0SS-W2026-07-31
09420082931176Spex Limited1256-1216-0SS-W2026-07-31
09420082931183Spex Limited1256-1218-0SS-W2026-07-31
09420082931190Spex Limited1256-1314-0SS-W2026-07-31
09420082931206Spex Limited1256-1316-0SS-W2026-07-31
09420082931213Spex Limited1256-1318-0SS-W2026-07-31
09420082931220Spex Limited1256-1412-0SS-W2026-07-31
09420082931237Spex Limited1256-1414-0SS-W2026-07-31
09420082931244Spex Limited1256-1416-0SS-W2026-07-31
09420082931251Spex Limited1256-1418-0SS-W2026-07-31
09420082931268Spex Limited1256-1420-0SS-W2026-07-31
09420082931275Spex Limited1256-1514-0SS-W2026-07-31
09420082931282Spex Limited1256-1516-0SS-W2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420082931091Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931107Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931114Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931121Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931138Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931145Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931152Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931169Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931176Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931183Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931190Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931206Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931213Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931220Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931237Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931244Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931251Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931268Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931275Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931282Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931299Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931305Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931312Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931329Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931336Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931343Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931350Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931367Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931374Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931381Spex LimitedSPEX LIMITEDKNN2026-07-31