BIRILLO

GUDID 08055715701195

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.

ORMESA SRL

Walking chair, non-foldable

• Primary Device ID: 08055715701195
• NIH Device Record Key: fb4f8052-f985-46cd-aa65-f7b12d6a96dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIRILLO
• Version Model Number: BIRILLO-3
• Company DUNS: 432070019
• Company Name: ORMESA SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055715701195 [Primary]

FDA Product Code

• ITJ: Walker, Mechanical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-10
• Device Publish Date: 2025-01-31

On-Brand Devices [BIRILLO]

• 08055715701201: Walking fram from a seated position, intended for all those children from 70 to 140 cm height, w
• 08055715701195: Walking fram from a seated position, intended for all those children from 70 to 140 cm height, w
• 08055715701188: Walking fram from a seated position, intended for all those children from 70 to 140 cm height, w
• 08055715701171: Walking fram from a seated position, intended for all those children from 70 to 140 cm height, w