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FDA Clearance

  • In 1979, the FDA cleared PEMF therapy for use in treating non-union fractures.
    Subsequently, the FDA cleared PEMF therapy for failed joint fusion following arthrodesis, failed spinal fusion, and congenital pseudoarthrosis.
  • In 1987, the FDA formally “grandfathered” 510(k) marketing clearance to PEMF therapy in the palliative treatment of postoperative edema and pain in superficial soft tissue.
  • In 2004, the FDA approved PEMF Therapy for cervical fusion patients at high-risk of non-fusion.
  • In 2008 the FDA approved “targeted microcurrent therapy”
  • In October of 2008, the FDA cleared PEMF Therapy for the treatment of Major Depressive Disorder.
  • On October 13th, 2015, the FDA reclassified PEMF devices from their existing Class 3 category to a Class 2 status, and most PEMF devices that are sold today in the United States are FDA registered as wellness devices.

From Wikipedia

History

Electromagnetic field therapy has been in use since the invention of electricity. It was widely adopted in East and Western Europe but its use was restricted to animals in North America until recently. Veterinarians became the first health professionals to use PEMF therapy, usually to heal broken legs in racehorses.

In 2004, pulsed electromagnetic field system was approved by FDA as an adjunct to cervical fusion surgery in patients at high risk for non-fusion. On 10/13/2015 the FDA reclassified PEMF devices from their existing Class 3 category to a Class 2 status. PEMF devices that have been FDA cleared to make health claims require a doctor’s prescription for use.

Although electricity’s potential to aid bone healing was reported as early as 1841, it was not until the mid-1950s that scientists seriously studied the subject. During the 1970s, Bassett and his team introduced a new approach for the treatment of delayed fractures, a technique that employed a very specific biphasic low frequency signal to be applied for non-union/delayed fractures. The use of electrical stimulation in the lumbosacral region was first attempted by Alan Dwyer of Australia. In 1974, he reported successful initiation of graft incorporation in 11 of 12 fusion patients.