FDA Clears OTC Electromagnetic Pulse Therapy for Musculoskeletal Pain Relief

The over-the-counter (OTC), drug-free medical device, ActiPatch®, has obtained a new 510(k) clearance from the Food and Drug Administration (FDA) for the adjunctive treatment of musculoskeletal pain.

ActiPatch was first cleared by the FDA in 2017 for the OTC treatment of knee osteoarthritis and plantar fasciitis. The topical device is a wearable version of pulsed shortwave therapy that consists of low voltage (3V) digital/analog electronics that produce a therapeutic radiofrequency field. The electromagnetic signal pulses to stimulate neuromodulation of the afferent nerves to reduce pain and inflammation. 

A 6-month prospective study evaluating the effectiveness of the ActiPatch in individuals with chronic pain (N=240) showed that the treatment provided a clinically meaningful reduction in pain in multiple anatomical locations following 7 days of treatment. Findings from the study also showed that in 85% of treated patients, pain relief was sustained for 6 months. Moreover, patients reported an improvement in functionality and a decrease in pain medication consumption.  

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