GRILLO ADAPTIVE SEATING

Basic Information

• Brand Name: GRILLO ADAPTIVE SEATING
• Primary DI: 08055715708293
• Version / Model: GRILLO ADAPTIVE SEATING ROSA mis. MEDIUM con 863 poggiatesta posturale
• 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: 947cff24-9f11-43cf-ab2d-a6c3e40d4537

Device Description

GRILLO ADAPTIVE SEATING is an adjustable configuration seating system intended for children and young people with disabilities who need special supports, supports and adjustments in carrying out daily, educational and recreational activities, easily adaptable thanks to its modularity. It allows the person with disabilities of varying complexity to be positioned in the most appropriate and functional posture for the different contexts of daily life. Indicated for users who have little or no control of the trunk and head and who need adequate stabilization at the pelvic level to be able to assume, in situations where residual functionality allows it, the most appropriate posture in the various contexts.

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
INM	Chair, With Casters	Physical Medicine	890.3100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58827	Assistive ergonomic chair, manually-adjusted	A non-electrical device, that may include pneumatically-assisted features, intended to support and position a patient (disabled and/or discomforted) in a sitting posture while performing activities of daily living, including work-related activities. It is designed with manually-operated ergonomic adjustments (e.g., height and position adjustments) to provide improved personal body posture and/or to help prevent/reduce physical problems associated with poor mobility or sedentary lifestyle. It is not a wheelchair.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08055715708293	GS1