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DONDOLINO

ORMESA SRL · Model DONDOLINO 1 · UDI-DI 08055715705490

INM

510(k) clearances

3,241

Adverse events (13 deaths)

Recalls

189

Facilities

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.

Recalls

Date	Firm	Reason
2021-11-19	Ki Mobility Llc	The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
2021-07-08	Sunrise Medical (US) LLC	The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
2021-07-08	Sunrise Medical (US) LLC	The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
2021-06-21	Accora Inc	The firm has identified a potential for the backrest to become detached from the chair.
2019-03-28	R82 A/S	Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
2017-06-30	R82 A/S	Replacement campaign on all units that have a gas spring head in aluminum.
2013-09-06	Winco Mfg., LLC	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when
2013-09-06	Winco Mfg., LLC	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when
2013-09-06	Winco Mfg., LLC	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when
2013-09-06	Winco Mfg., LLC	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.