We are the only U.S. company that is UL Safety Certified for medical device so we can carry product liability Insurance. Plus we have the only PEMF manufactured units to be ISO 13485 Certified. Currently, our machines are engaged in three clinical trials in the United States. These studies are for final submission to the FDA for U.S. FDA clearance, and for adding human use approval in other countries.
To our knowledge, Get Pulsed, LLC is the only manufacturer conducting clinical trials in the USA to demonstrate the health benefits and safety of our product.
Current PEMF clinical trials are:
- Myalgia and Arthralgia of the knee (Arthritis) Miller School of Medicine at University of Miami
- Pressure wound healing (bed sores) Veterans Administration Hospital, Long Beach, CA
- Venous wound healing Henry Ford Hospital, Detroit, MI
In other countries, PEMF has been a mainstream therapy for over 30 years. There have been over 2800 clinical trials completed using many different PEMF devices in many different countries, all with positive results. Our devices are CE (Human) approved in Europe and 127 other countries.