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Gloreha Professional 2

IDROGENET SRL · Model 1 · UDI-DI 08055713760019

BXB
10
510(k) clearances
150
Adverse events
6
Recalls
116
Facilities

Description

The Gloreha Professional 2 (GP2) is a neuromotor rehabilitation device designed to support recovery for patients with neuromuscular impairments. This electrically powered device mobilizes the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints, aiding finger movement. Through an interactive virtual software program, GP2 combines motor therapy with visual and auditory stimuli. This targeted approach helps rehabilitate upper limb functionality by reinforcing motor patterns essential for daily tasks.

Recalls

DateFirmReason
2024-08-01Btt Health GmbhSome power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical devic
2019-07-29MOTEK MEDICAL B.V.The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable gu
2013-06-12Accelerated Care Plus CorporationAn anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.
2012-11-12BioMotion Medical Systems, LLCBioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involvin
2011-07-15Alter-G, IncorporatedPotential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting.
2009-05-27Hocoma AGChanges to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation

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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.