FDA.reportPublic FDA data

Spex

Primary DI
09420051708754
Brand
Spex
Company
SPEX LIMITED
Model
1420-1020-001_028
Device description
Wonderseat Space Size 0, Single Mount, Tray (028 Calypso Pink)
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
KNNComponents, Wheelchair
KNOAccessories, Wheelchair

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420051708754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420051708754094200517087549420051708754

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
748649195
Device count
1
Premarket exempt
true
Kit
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
09420082689060Spex SeatingSPEX LIMITEDKNN2026-04-30
09420082689077Spex SeatingSPEX LIMITEDKNN2026-04-30
09420082695511Spex SeatingSPEX LIMITEDKNN2026-04-30
10080196470723MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-16
10884389115954MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-16
40884389115788MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-13
09420082699441Spex SeatingSPEX LIMITEDKNN2026-04-04
09420082699458Spex SeatingSPEX LIMITEDKNN2026-04-04
00810178884575ViveVIVE HEALTH LLCKNO2025-12-05
00810178884889ViveVIVE HEALTH LLCKNO2025-12-05
00810178884896ViveVIVE HEALTH LLCKNO2025-12-05
00810178884902ViveVIVE HEALTH LLCKNO2025-12-05
09420051799851Spex SeatingSPEX LIMITEDKNN2025-11-21
09420051706521Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051725195Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051747517Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051747746Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051747852Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051747869Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051770560Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051770584Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051770676Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051770690Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051770805Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051794672Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051794689Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051797512Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051797529Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051797550Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051797567Spex LimitedSPEX LIMITEDKNN2025-11-07