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STANDY

ORMESA SRL · Model STANDY-3 medium · UDI-DI 08055715705087

INM

510(k) clearances

3,241

Adverse events (13 deaths)

Recalls

189

Facilities

Description

Vertical standing frame for the acquisition and maintenance of an upright position and the training of the antigravity muscles of young, adult or elderly who cannot acquire and maintain them independently. Indicated for persons with functional deficits in verticalization and in maintaining an upright position, who have a minimum residual control of the trunk and head; users suffering from pathologies with alteration and impairment of the residual postural control, in which the load on the lower limbs is allowed, to improve bone density, ventilatory capacity, intestinal peristalsis, bladder function, blood circulation.

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.