Marodyne LiV
BTT Health GmbH · Model 10107 · UDI-DI 04260658910007
Description
Marodyne LiV is a therapeutic medical device for bone growth stimulation. Specific mechanical vibrations applied to the body respectively to the tissue have a positive impact to the bone stability and the entire musculoskeletal system. The Marodyne System emits vertical, low intensity vibrations to the human body. Based on this application, BTT Health GmbH specifies the below indications, where Marodyne LiV can successfully be applied: • Safe and effective treatment of osteoporosis • Maintain and increase bone mineral density (BMD) • Building muscle strength & muscle mass in the legs • Stimulate blood circulation & lymphatic flow • As a fall prevention device by improving balance,postural control and coordination
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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