The ActiPatch was already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain) in 2017. The latest clearance expands these indications to cover all musculoskeletal pain complaints. Also, 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, president of BioElectronics, stated, “The company intends to capitalize on this new clearance by offering additional products to retail channel partners, in alignment with our 2020 strategy to prioritize the OEM (Original Equipment Manufacturer) aspects of our business.”
The 510(k) application was prepared by the R&D team comprised of Kenneth McLeod, Ph.D., director of Clinical Science and Engineering Research, State University of New York at Binghamton; Richard Staelin, Ph.D., Gregory Mario and Jeremy Mario Professor, Duke University; Ian Rawe, Ph.D., director of Clinical Research, BioElectronics; and Sree Koneru, Ph.D., VP Product Development, BioElectronics.