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Gloreha Active Package

IDROGENET SRL · Model 1 · UDI-DI 08055713760026

BXB

510(k) clearances

150

Adverse events

Recalls

116

Facilities

Description

The Gloreha Active Package (GAP) is a neuromotor rehabilitation device designed to support recovery for patients with neuromuscular impairments. It consists of a set of sensorized gloves connected to a control system that detects and processes movement data. This device facilitates the recognition, enhancement, and training of active finger flexion and extension movements, promoting effective motor recovery. GAP also supports bimanual therapy, active-assisted exercises, and interactive rehabilitation games, providing an engaging and dynamic therapy experience.

Recalls

Date	Firm	Reason
2024-08-01	Btt Health Gmbh	Some 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
2019-07-29	MOTEK 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
2013-06-12	Accelerated Care Plus Corporation	An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.
2012-11-12	BioMotion Medical Systems, LLC	BioMotion 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
2011-07-15	Alter-G, Incorporated	Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting.
2009-05-27	Hocoma AG	Changes 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.