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Homemedica - Medizintechnik GmbH › OmniCycle® Revo

OmniCycle® Revo

medica - Medizintechnik GmbH · Model 01.05.ZZ · UDI-DI 04041925006308

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

Description

General Description: The system is a therapeutic device for circular passive, assistive or active movement. The transition from motor-supported passive to active therapy is seamless. The medical device can be used in a sitting position and the pivoting drive makes it easy to switch from lower extremity to upper extremity mode. The system can be used stationary or wheeled from room to room effortlessly. With the barrier free base frame and using the pivoting drive unit, the device can be individually positioned for each patient. The device can be quickly adapted to the patient through tool-free adjustments and various accessories. The software offers goal-oriented gamification, assessments and documentation to track therapy progress. The encased crank design ensures effective disinfection and safety. The system therefore facilitates safe, easy and efficient therapy for active persons as well as weak patients with particular needs. The equipment at the device ensure a stable, non-slip, and tilt-resistant position both during preparation and throughout the training session. Suitable devices guarantee a non-slip and tilt resistant stand during the training preparation of the device as well as during the training. The therapy drive unit moves the support devices for the legs (footrests) and arms (e.g. therapy grips) in a circular motion. The patient’s movement is controlled by the therapy drive unit and limited by the selected crank radius. Both the upper and lower extremities are trained by the same drive unit. The therapy drive unit never moves the arms and legs simultaneously. The interfaces for the arm and leg accessories are designed for easy attachment and exchange of specific options. This allows optimal securing of the patient according to their individual needs and degree of impairment. Additional description: OmniCycle® Revo with electrical height adjustment and mobility chassis.

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.