DONDOLINO

Primary DI
08055715705513
Brand
DONDOLINO
Company
ORMESA SRL
Model
DONDOLINO 3
Device description
Tilting vertical standing frame indicated for the acquisition and maintenance of an upright position and the training of the antigravity muscles of children who cannot acquire and maintain them independently. Indicated for users suffering from pathologies that determine a deficit of postural control, in which the load of the lower limbs is still allowed, to improve bone density, ventilatory capacity, intestinal peristalsis, bladder function, blood circulation and for such as the semi-prone positioning, allows to stimulate the straightening reactions of the trunk and head and to work against gravity.
Published
2025-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08055715705513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055715705513080557157055138055715705513

GMDN Terms#

Term, Definition table
TermDefinition
Manual standerA manually-powered, mobile device designed to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, and flexibility); it is neither intended to facilitate gait nor assist standing transfer. It typically consists of a seat, sling and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), wheels, and a manual mechanical lifting mechanism whereby the patient is raised from a supine, prone, and/or seated position by themselves or with the assistance of a healthcare provider. It includes wheels for reorientation.

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
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054040402432GRILLOGRILLO SMALL ANT.PA (809 MINI IBR.)2025-09-15
08054040402449GRILLOGRILLO SMALL ANT.P PELV.MINI IBRID2025-09-15
08054040402463GRILLOGRILLO SMALL ANT.(P/T COMP.MINI)IBR2025-09-15
08054040402470GRILLOGRILLO MEDIUM ANT.P(SMALL) IBRID.2025-09-15
08054040402487GRILLOGRILLO MED.POST.PT IBR(PEL.S/TOR.S)2025-09-15
08054040402494GRILLOGRILLO MED.POST.PT IBR(PEL.S)2025-09-15
08054040402500GRILLOGRILLO MED.POST.PA IBRID (PELV.S)2025-09-15
08054040402524GRILLOGRILLO MED.POST.PA IBR(PEL.S-BRAG.M2025-09-15
08054040402531GRILLOGRILLO SMALL ANT.PA(PEL/ANT.MIN)IBR2025-09-15
08054040402555GRILLOGRILLO SMALL ANT.PT(TOR./MINI)IBR2025-09-15
08054040402562GRILLOGRILLO SMALL POST.P PELV.MINI IBR2025-09-15
08054040402579GRILLOGRILLO SMALL POST.PA PELV.MINI IBR2025-09-15
08055715700105GRILLOGRILLO SMALL POSTERIORE PT2025-01-31
08055715700112GRILLOGRILLO SMALL POSTERIORE PA2025-01-31
08055715700129GRILLOGRILLO SMALL POSTERIORE P2025-01-31
08055715700136GRILLOGRILLO MEDIUM ANTERIORE PT2025-01-31
08055715700143GRILLOGRILLO MEDIUM ANTERIORE PA2025-01-31
08055715700150GRILLOGRILLO MEDIUM ANTERIORE P2025-01-31
08055715700167GRILLOGRILLO MEDIUM POSTERIORE PT2025-01-31
08055715700174GRILLOGRILLO MEDIUM POSTERIORE PA2025-01-31

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