About PEMF
- Acupuncture
- Alzheimer’s Disease
- Atrial Fibrillation (A-Fib)
- Avoiding Steroid Injections
- Back Pain and Lumbar Disc Disease
- Bioregulation Therapy (BRT)
- Blood Viscosity
- Breast Cancer
- Cancer
- Cataracts
- Cell Injury and Anti-Aging
- Degenerative Disc Problems
- Dental Issues
- Depression and Anxiety
- Diabetes
- Glaucoma
- Heart Conditions
- Inflammation
- Lyme Disease
- Multiple Sclerosis (MS)
- Neuromyelitis Optica (NMO)
- Osteoarthritis (OA)
- Pain Management
- Paraplegia and Spinal Cord Injury
- Prostate Hyperplasia
- Psychiatric and Neurological Conditions
- Restoring Alkaline Balance
- Scleroderma
- Seizures and Epilepsy
- Shingles
- Sleep Disorders
- Smoking Cessation
- Sports Injury Recovery
- Stroke Rehabilitation
- Urinary Incontinence and OAB
- Vocal Cords
- Nocturnal Enuresis (Bedwetting)
About FDA Registration and Approval
The FDA registers medical devices, and the FDA approves medical devices. Do not confuse registration with approval. Often companies tout their system as FDA registered, hoping that the customer will assume that means the same thing as FDA approved. It is not.
If a PEMF System is FDA registered, that only means that the FDA knows the item is being manufactured or imported into the United States. This is not a a guarantee of device safety or efficacy for a particular medical indication.
All PEMF Devices imported into the United States have to have FDA registration. FDA approval and oversight is also not necessarily a guarantee of value or safety. There are actually some FDA approved PEMF Devices, so we know that the FDA does approve of the use of electromagnetic fields for certain therapeutic uses.
Furthermore, most manufacturers do not want to be FDA approved. You read that correctly. They are not seeking FDA approval. There are many reasons for this, including the expensive cost associated with seeking FDA approval. FDA approval also comes with the stipulation that the product be condition-specific. Because PEMF Device applications are at such a basic, cellular level, choosing only one health condition would be a disservice to both the brand and the consumer. Additionally, PEMF Systems are, first and foremost, wellness devices. It is not medication. A magnetic field does not change the chemistry of your body. A magnetic field acts on the most basic of biological functions – the cellular level. It is more physics than medicine.
FDA Listing & Status
FDA establishment Registration and Device Listing PEMF Systems, Inc FDA Registration page
Our Manufacturer, PEMF Systems, Inc, secured a FDA Establishment Registration & Device Listing and is the first high powered PEMF manufacturer in the US market to reach this achievement. This process started in 2006 by securing the proper FDA applications and vetting FDA medical consultants. Now two decades later and significant funding to submit our devices to 3rd party testing labs (InterTek) and finally obtaining crucial electrical safety certifications (2021), this first benchmark has been achieved.
The next phase is continuing clinical studies at the Henry Ford Hospital and Long Beach VA to obtain FDA Clearances and eventual insurance coverage for skin wound healing. FDA Clearances for additional medical indications to follow.