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Gloreha Aria

IDROGENET SRL · Model 1 · UDI-DI 08055713760033

ION
10
510(k) clearances
116
Adverse events (2 deaths)
2
Recalls
255
Facilities

Description

The Gloreha Aria (GAR) is a sensor-based therapeutic device designed for upper limb rehabilitation and neurocognitive training. The optical sensor detects hand movements and offers interactive programs and games to enhance motor skills, coordination, and visuospatial abilities. Additionally, GAR focuses on improving cognitive functions such as attention, memory, and problem-solving. By integrating motor and cognitive tasks, GAR helps train divided attention, which is essential for performing Activities of Daily Living (ADLs).

Recalls

DateFirmReason
2015-03-27Amtryke LLCProduct is being recalled due to complaints of cracked frames.
2011-07-11North Coast Medical IncPotential for plastic D-ring to break during use and cause injury.

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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.