FDA.reportPublic FDA data

Spex Limited

Primary DI
09420051709928
Brand
Spex Limited
Company
SPEX LIMITED
Model
1250-3955-000
Device description
TSS Lite Contouring Kit
Published
2024-09-26
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
IMSSupport, Head And Trunk, Wheelchair
KNNComponents, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMSSupport, Head And Trunk, WheelchairPhysical Medicine1
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420051709928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420051709928094200517099289420051709928

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair back restA padded support (typically vinyl covered) designed to attach to the back of a wheelchair. It typically replaces the wheelchair's sling upholstery and provides the wheelchair occupant with improved back support, posture, air circulation, and comfort.

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
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
10194484321953CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321960CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321977CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321984CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321991CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322004CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322011CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322028CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322035CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322042CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322059CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322073CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322080CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322097CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322103CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322110CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322127CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322134CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322141CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322158CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322165CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322189CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22