FDA.reportPublic FDA data

Spex Limited

Primary DI
09420051798632
Brand
Spex Limited
Company
SPEX LIMITED
Model
PROMO-ATPKIT-14
Device description
"Spex Assistive Technology Professional (ATP) Accessory Kit - Paediatric 14""Kit Incudes 1259-2400-100 Spex Back Support Quad Mount Hardware1266-2501-100 Axial Biangular Lateral Bracket (for use with Axial Biangular Lateral Pad)1266-2301-100 Spex Swing-Away Lateral Bracket, Axial; includes protective neoprene sleeve1274-1282-000 Stylo 260 Fixed Extended Mechanism1250-3955-000 TSS Lite Contouring Kit 1266-3012-400 Narrow Straight lateral pad with standard cover, size 2; 95mm high x 180mm deep1266-3012-800 Narrow Straight lateral pad with Comfy-cover, size 2; 95mm high x 180mm deep1266-3044-400 Axial Biangular Lateral Pad Size 4, with 12mm Pressure Reduction padding, Standard cover 1275-0043-000 Spex Standard Lateral Head Support Head Support pad (000 Black) 1400-6692-000 Spex Shoulder Strap Guides/Retainer, Pair"
Published
2025-10-01
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
IMSSupport, Head And Trunk, Wheelchair
KNNComponents, Wheelchair
KNOAccessories, Wheelchair

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420051798632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420051798632094200517986329420051798632

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair/chair/stander occupant restraint/supportA rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair/stander and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle. This device may also include the extensions needed to attach this device and may be available in various sizes.

Contacts#

Phone, Email table
PhoneEmail
+64330079790solutions@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
09420082931091Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931107Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931114Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931121Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931138Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931145Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931152Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931169Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931176Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931183Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931190Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931206Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931213Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931220Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931237Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931244Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931251Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931268Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931275Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931282Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931299Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931305Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931312Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931329Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931336Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931343Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931350Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931367Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931374Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931381Spex LimitedSPEX LIMITEDKNN2026-07-31