FDA.reportPublic FDA data

Spex Limited

Primary DI
09420051711143
Brand
Spex Limited
Company
SPEX LIMITED
Model
1125-2949-600_044
Device description
Spare cover, user matched, Spex cushion - Bumblebee Yellow
Published
2023-11-16
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
IMPCushion, Wheelchair
KNOAccessories, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420051711143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420051711143094200517111439420051711143

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
+6433079790solutions@spexseating.com

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
00810226442245ViveVIVE HEALTH LLCKNO2026-08-21
00810226442290ViveVIVE HEALTH LLCKNO2026-08-21
00810226441965ViveVIVE HEALTH LLCKNO2026-08-14
00810226441972ViveVIVE HEALTH LLCKNO2026-08-14
00810226441385ViveVIVE HEALTH LLCKNO2026-07-28
00860014392757ICON Oxygen Tank HolderCarrier Medical LLCKNO2026-07-13
00860014392764PerfectFit Oxygen Tank HolderCarrier Medical LLCKNO2026-07-13
07540147004040Matrx MAC BackMotion Concepts IncIMP2026-07-03
07540147004057Matrx MAC-HUG BackMotion Concepts IncIMP2026-07-03
00761887005495CorCytePRYOR PRODUCTSKNO2026-06-22
00810178889952ViveVIVE HEALTH LLCKNO2026-06-10
00761887005402PryorPRYOR PRODUCTSKNO2026-05-31
04034089093246Abduction block (Hercules Prime, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089097640crotch pad with magnetic lock (Hercules Prime)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103334Back cushion, seat reducer (Swifty 3)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103341Seat minimizer Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103358Seat width reducer Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103365Lateral trunk supports, swing-away, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103372Lateral head supports, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103402Frame padding Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103419Canopy Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103433Rain poncho Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103464Pneumatic wheels, set, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103471under seat storage bag Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103488under seat storage basket Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103495Lateral trunk supports, rigid, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103501Drum brake, set, Swifty 3Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089103648Chin support rehabThomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
04034089104010Incontinence Seat Cover size LThomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftKNO2026-05-29
09420082696471Spex LimitedSPEX LIMITEDIMP2025-11-07