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Extracorporeal Magnetotransduction Therapy (EMTT): STORZ MEDICAL’s MAGNETOLITH receives 510(k) clearance from the FDA

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On 3 May 2021, STORZ MEDICAL received the 510(k) clearance for the MAGNETOLITH® from the U.S. Food and Drug Administration (FDA). The therapy device is now cleared in the USA (as a class II medical device) for the following indications:

  • Relaxation of muscle spasms
  • Prevention or retardation of disuse atrophy
  • Increase local blood circulation
  • Muscle re-education
  • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
  • Maintaining or increasing range of motion

»Extracorporeal Magnetotransduction Therapy (EMTT®) with the MAGNETOLITH® is an excellent addition to our shock wave portfolio on the US market. We already have well over 100 device orders,« says a delighted Alessandro Saccucci, STORZ MEDICAL’s Sales Director. »The 510(k) clearance opens up promising growth opportunities with a signal effect for other countries as well.«

EMTT® differs from general forms of magnetic field therapy or PEMF due to the high oscillation frequency of 100 – 300 kHz. This property enables a high penetration depth and opens up a large range of indications. Treatment with the MAGNETOLITH® requires little effort, is non-invasive and comfortable for the patient. . One treatment session lasts between 5 and 20 minutes, 6 to 8 sessions are required depending on the indication.

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Sunday, 05 December 2021

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