FDA.reportPublic FDA data

Spex Limited

Primary DI
09420051716056
Brand
Spex Limited
Company
SPEX LIMITED
Model
1102-1818-1CHC
Device description
"Constructa Shape Cushion, 18"" Wide x 18"" Deep, High Contour. Includes Strategic Positioning Kit and Spare Cover"
Published
2023-12-19
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
09420051716056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420051716056094200517160569420051716056

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
+64330079790solutions@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
09420082689060Spex Seating1255-CUST-0092026-04-30
09420082689077Spex Seating1255-CUST-0522026-04-30
09420082695511Spex Seating1256-CUST-0062026-04-30
09420082699441Spex Seating1259-2850-2002026-04-04
09420082699458Spex Seating1259-2860-2002026-04-04
09420082699434Spex Seating0079-0015-0002026-02-20
09420051799745Spex Seating1102-1010-WSS-F2025-12-12
09420051799752Spex Seating1102-1012-WSS-FI2025-12-12
09420051799769Spex Seating1102-1200-SSF2025-12-12
09420051799776Spex Seating1102-1212-WSS-F2025-12-12
09420051799783Spex Seating1102-1214-WSS-F2025-12-12
09420051799790Spex Seating1102-1216-WSS-F2025-12-12
09420051799820Spex Seating1102-1414-WSS-F2025-12-12
09420051799837Spex Seating1102-1416-WSS-F2025-12-12
09420051799844Spex Seating1102-1418-WSS-F2025-12-12
09420051799738Spex Limited1102-1000-FSS2025-12-05
09420051799806Spex Limited1102-1400-FSS2025-12-05
09420051799813Spex Limited1102-1400-SSF2025-12-05
09420051799851Spex Seating1209-2712-3002025-11-21
09420051706521Spex Limited1156-5822-4102025-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10080196312276MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
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
09420082696563Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696570Spex LimitedSPEX LIMITEDIMP2025-11-07