Spex Limited

Basic Information

• Brand Name: Spex Limited
• Primary DI: 09420051798632
• Version / Model: PROMO-ATPKIT-14
• Company Name: SPEX LIMITED
• Labeler DUNS: 748649195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-01
• Public Version: 1
• Public Version Date: 2025-10-09
• Public Version Status: New
• Public Device Record Key: 85e57117-7c01-4dd0-98d6-2465ce81978b

Device Description

Spex Assistive Technology Professional (ATP) Accessory Kit - Paediatric 14" Kit Incudes 1259-2400-100 Spex Back Support Quad Mount Hardware 1266-2501-100 Axial Biangular Lateral Bracket (for use with Axial Biangular Lateral Pad) 1266-2301-100 Spex Swing-Away Lateral Bracket, Axial; includes protective neoprene sleeve 1274-1282-000 Stylo 260 Fixed Extended Mechanism 1250-3955-000 TSS Lite Contouring Kit 1266-3012-400 Narrow Straight lateral pad with standard cover, size 2; 95mm high x 180mm deep 1266-3012-800 Narrow Straight lateral pad with Comfy-cover, size 2; 95mm high x 180mm deep 1266-3044-400 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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNN	Components, Wheelchair	Physical Medicine	890.3920	1
KNO	Accessories, Wheelchair	Physical Medicine	890.3910	1
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	890.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13356	Wheelchair/chair/stander occupant restraint/support	A 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.	No	Active
36254	Wheelchair back rest	A 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.	No	Active
41119	Wheelchair/chair/stander headrest	A padded device attached to a wheelchair, a disability-supportive chair, and/or a stander to provide a disabled patient with additional head support and comfort while in a sitting and/or standing position. This device will also include the extensions (e.g., a metal insert, screws) needed to attach this device. It may be available in various shapes and sizes, and it may be adjustable.	No	Active
45887	Wheelchair head/trunk support, prefabricated	A 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. It may include armrests, a cushioned seat, a belt/harness, thigh support, and/or a tray table. It might additionally be designed for use as a car seat to provide support in vehicles during transportation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09420051798632	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]