PEMF therapy is an FDA-approved therapy when used in 5 specific functions, before being reclassified to a wellness device and no longer requiring FDA approval for specific functions.
Its FDA approval began in the late 1970s, and continues today, as a Class 2 wellness device.
PEMF therapy’s history with FDA approval has shifted over the years, as its first approval was for a specific type of treatment, and its use was identified as one intended for clinics and hospitals (including veterinary practices).
The FDA has different approval systems for different items, most often based on the safety concerns and risks associated with a product seeking approval.
PEMF therapy was initially approved under the heading of Class 3 devices, which is the class typically devoted to medical implements and equipment.
Class 3 is designed to make sure that all medical equipment is of the safest grade, and that doctors are not committing fraud by offering treatments that do not have a consistent body of evidence supporting their use.
An x-ray machine, for instance, would require FDA approval as a class 3 device. Class 2 devices do not require as much oversight, as they are considered relatively risk-free or low-risk wellness products.
Prior to being reclassified, the FDA gave approval to PEMF therapy devices to treat five conditions, including the healing of nonunion fractures, urinary incontinence and muscle stimulation, cervical fusion, depression and anxiety, and brain cancer.
The approval for each of these treatment areas does not necessarily mean that PEMF therapy is ineffective at treating other issues; instead, it means that the FDA was petitioned for approval for these specific issues, citing a host of positive research and evidence as proof that PEMF therapy can and should be used in these applications.
The change from a Class 3 approval to a Class 2 approval simply means that PEMF machines are no longer regarded entirely as medical devices, bearing their own risks and presenting hazards that warrant careful use.
Instead, PEMF devices are considered wellness items, as they have been shown to support wellness, and post little to no risk to the general population.
This change was not decided upon due to negative press or a debunking of health claims; instead, it was as a result of consistent evidence supporting its use as a general health support, rather than functioning solely as a targeted therapeutic device.
The shift has allowed more PEMF devices designed for home use to enter the market, making PEMF therapy more widely available.
FDA approval of PEMF devices means that PEMF therapy has shown promise as a treatment modality for numerous health applications, can successfully accomplish the feats it claims to accomplish, and has a healthy track record of safety and efficacy.
PEMF therapy devices can be registered individually, with different companies petitioning for FDA approval for their particular PEMF machine, and PEMF therapy as a whole can be recognized by the FDA, as is currently the case.
The FDA has also cleared PEMF therapy as a viable option for animals, and many veterinary practices utilize the therapy with their animal patients.