THERA-Trainer bemo
medica - Medizintechnik GmbH · Model 02.YY.ZZ · UDI-DI 04041925006247
Description
The THERA-Trainer bemo is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The transition from passive to active therapy is seamless. The medical device is used for leg exercise in a lying or almost lying position, e.g. in a hospital/nursing bed or on a therapy couch, and for upper body exercise in a lying, almost lying or seated position, e.g. in a hospital/nursing bed, therapy couch, chair or wheelchair. The movement is managed by the drive unit and is limited in extent by the selected crank radius. The drive of the upper extremities and the lower extremities is managed by the same drive unit. The drive unit will never move the arms and legs simultaneously. The drive unit drives a positioning device for legs (footrests) and arms (therapy grips) in a circular motion. The different positioning devices should be easily interchangeable by the operator. With the chassis and the electronic lifting column, the drive unit can be positioned individually on the patient. The wide chassis with four lockable castors ensures that the THERA-Trainer bemo does not slip or tip over, both during exercise preparation and during exercise. Through four lockable castors, the THERA-Trainer bemo can be easily transported to different places of use or storage.
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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