FDA.reportPublic FDA data

GRILLO ADAPTIVE SEATING

Primary DI
08055715708101
Brand
GRILLO ADAPTIVE SEATING
Company
ORMESA SRL
Model
GRILLO ADAPTIVE SEATING ROSSO mis. mini con 863 p
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.
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INMChair, With Casters

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055715708101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055715708101080557157081018055715708101

GMDN Terms#

Term, Definition table
TermDefinition
Assistive ergonomic chair, manually-adjustedA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
432070019
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054040402029FRAME RUNNERFRAME RUNNER SMALL 2R24’’ 1R20’’2025-10-15
08054040402036FRAME RUNNERFRAME RUNNER SMALL 3R20’’2025-10-15
08054040401275FRAME RUNNER"FRAME RUNNER MEDIUM FISS.3R24"""2025-09-20
08054040401282FRAME RUNNER"FRAME RUNNER LARGE FISS.3R26"" "2025-09-20
08054040401299FRAME RUNNERFRAME RUNNER MEDIUM RIBALT.3R24 2025-09-20
08054040401305FRAME RUNNERFRAME RUNNER LARGE RIBALT.3R262025-09-20
08054040401312FRAME RUNNER"FRAME RUNNER MEDIUM FISS.2R24""1R20"""2025-09-20
08054040401329FRAME RUNNER"FRAME RUNNER MEDIUM RIB.2R24""1R20"""2025-09-20
08054040401336FRAME RUNNER"FRAME RUNNER MEDIUM FISS.2R26""1R24"""2025-09-20
08054040401343FRAME RUNNER"FRAME RUNNER MEDIUM RIB.2R26""1R24"""2025-09-20
08054040401350FRAME RUNNERFRAME RUNNER LARGE FISS.3R242025-09-20
08054040401367FRAME RUNNERFRAME RUNNER LARGE RIB.3R242025-09-20
08054040401374FRAME RUNNER"FRAME RUNNER LARGE FISS.2R26""1R24"""2025-09-20
08054040401381FRAME RUNNER"FRAME RUNNER LARGE RIB.2R26""1R24"""2025-09-20
08054040401398FRAME RUNNER"FRAME RUNNER LARGE FISS.2R24""1R26"""2025-09-20
08054040401404FRAME RUNNER"FRAME RUNNER LARGE RIB.2R24""1R26"""2025-09-20
08054040401411FRAME RUNNER"FRAME RUNNER LARGE FISS.2R28""1R26"""2025-09-20
08054040401428FRAME RUNNER"FRAME RUNNER LARGE RIB.2R28""1R26"""2025-09-20
08054040401435FRAME RUNNERFRAME RUNNER LARGE FISS.3R282025-09-20
08054040401442FRAME RUNNERFRAME RUNNER LARGE RIB.3R282025-09-20

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Primary DI, Brand, Company table
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