ActiPatch Electromagnetic Therapy Given FDA Premarket Notification in the U.S. for Musculoskeletal Pain

ActiPatch Electromagnetic Therapy Given FDA Premarket Notification in the U.S. for Musculoskeletal Pain
The U.S. Food and Drug Administration (FDA) has cleared BioElectronics Corporation’s premarket notification — also known as a 510(k) — for its ActiPatch medical device as an over-the-counter add-on therapy for any form of musculoskeletal pain. A 510(k) is an application made to the FDA to demonstrate that the proposed device is at least as safe and effective as a legally marketed device. This clearance expands previously FDA-cleared ActiPatch’s indications — pain from knee osteoarthritis and plantar fasciitis (heel pain) — to cover any form of musculoskeletal pain, including that caused by fibromyalgia. “With the latest clearance, ActiPatch remains the only pulsed shortwave therapy (PSWT) device with an over-the-counter clearance for treating any form of musculoskeletal pain,” Kelly Whelan, BioElectronics’ president, said in a press release. A PSWT device delivers electromagnetic fields in short pul
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