Materialise Footscan Pro Level pressure plate

Basic Information

• Brand Name: Materialise Footscan Pro Level pressure plate
• Primary DI: 05425026002008
• Version / Model: Footscan Pro Small
• Company Name: Materialise Motion
• Labeler DUNS: 370554067
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-31
• Public Version: 1
• Public Version Date: 2026-02-09
• Public Version Status: New
• Public Device Record Key: 4f624de3-d184-43b3-bbcd-f08b6b1b02dc

Device Description

The Materialise footscan Pro Level pressure plate is intended to capture static and dynamic plantar pressure during balance and/or gait (walking/running) exercises.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	890.1600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62788	Plantar pressure/morphology assessment unit	An electronic device intended to detect plantar pressure distribution and/or morphology to help assess abnormal pressure and/or structural deformities (e.g., flat foot, valgus toe) on the soles of the feet. It is a freestanding platform upon which the patient’s feet are placed and evaluated by either optical-based technology (e.g., photometric imaging, 3-D camera) or pressure resistive sensors; captured data is transmitted to an off-the-shelf tablet/computer for recording, display and analysis, sometimes with dedicated software. The device is often used to help design therapeutic footwear such as orthotic shoes and insoles.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05425026002008	GS1