FDA.report

GRILLO CHAIR

Primary DI
08055715708316
Brand
GRILLO CHAIR
Company
ORMESA SRL
Model
GRILLO CHAIR BLU mis.SMALL
Device description
Ergonomic and adjustable chair suitable for children with disabilities who need support during recreational, educational and daily life activities. It is an ergonomically designed seat designed to ensure maximum comfort for the child who, by improving their sitting posture, is encouraged to develop motor skills and hand-eye coordination, attention and therefore social inclusion.
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
INNChair, Adjustable, Mechanical

Product Code Classifications

CodeDeviceSpecialtyClass
INNChair, Adjustable, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08055715708316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08055715708316080557157083168055715708316

GMDN Terms

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

Regulatory Flags

DUNS number
432070019
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08054040401282FRAME RUNNERFRAME RUNNER LARGE FISS.3R26" 2025-09-20
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08054040401404FRAME RUNNERFRAME RUNNER LARGE RIB.2R24"1R26"2025-09-20
08054040401411FRAME RUNNERFRAME RUNNER LARGE FISS.2R28"1R26"2025-09-20
08054040401428FRAME RUNNERFRAME 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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