BIRILLO

Basic Information

• Brand Name: BIRILLO
• Primary DI: 08055715701201
• Version / Model: BIRILLO-4
• Company Name: ORMESA SRL
• Labeler DUNS: 432070019
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-31
• Public Version: 1
• Public Version Date: 2025-02-10
• Public Version Status: New
• Public Device Record Key: 8552b709-dcbe-43db-87e8-ff778d9fbcb5

Device Description

Walking fram from a seated position, intended for all those children from 70 to 140 cm height, with functional deficits who need containment a pelvis level (in particular) and trunk level, through the classic “Bobath angle” and that, through the use of "stepping" made possible by the presence of the wheels under the seat, are able to move into the surrounding environment and explore it, becoming a significant stimulus towards greater autonomy. To use the walker, the user needs sufficient strength in the upper and lower limbs, Ability to transfer the load from one limb to another, Head and trunk control, Minimum flexion of the elbows 15-20°, 90° hip flexion.

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
ITJ	Walker, Mechanical	Physical Medicine	890.3825	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38704	Walking chair, non-foldable	An all-wheeled mobility aid in the form of a non-foldable framework that has a built-in seat or sling that supports a disabled or geriatric person in a sitting position while walking. It is constructed of lightweight metal, plastic, rubber and textile materials in the shape of a low centre-of-gravity mobile support structure in which the user walks while seated. The device is non-foldable and may include forearm supports and a braking mechanism.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08055715701201	GS1