FDA.reportPublic FDA data

Spex Limited

Primary DI
09420082696563
Brand
Spex Limited
Company
SPEX LIMITED
Model
1102-1214-WSS
Device description
"Wonderseat Cushion, 12"" Wide x 14"" Deep, SuperHigh Contour"
Published
2025-11-07
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
09420082696563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420082696563094200826965639420082696563

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.

Contacts#

Phone, Email table
PhoneEmail
+6433079790solutions@spexseating.com

Regulatory Flags#

DUNS number
748649195
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
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
07540147004040Matrx MAC BackMotion Concepts IncIMP2026-07-03
07540147004057Matrx MAC-HUG BackMotion Concepts IncIMP2026-07-03
09420082696471Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696488Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696495Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696501Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696518Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696525Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696532Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696549Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696556Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696570Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696587Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696594Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696600Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696617Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696624Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696631Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696648Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696655Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696662Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696679Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696686Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696693Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696709Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696716Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696723Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696730Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696747Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696754Spex LimitedSPEX LIMITEDIMP2025-11-07