Non-invasive electroceutical devices manufacturer BioElectronics has received 510(k) approval from the US Food and Drug Administration (FDA) for its drug-free ActiPatch medical device.
The FDA has granted marketing approval for the device as an over-the-counter adjunctive treatment of musculoskeletal pain.
ActiPatch offers long-term chronic pain relief by deploying electromagnetic pulse therapy and works against back pain, knee pain, muscle & joint pain, arthritis, sciatica, fibromyalgia, strains and sprains.
BioElectronics president Kelly Whelan said: “The Company intends to capitalise 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.
“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.”
BioElectronics sales and marketing vice president Keith Nalepka said: “The expanded clearance paves the way for new products to be marketed with approved medical claims for musculoskeletal pain, for instance, in the back, knee, hips, wrists, elbow and ankle.”
In 2017, BioElectronics secured FDA approval for its ActiPatch, authorised for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis.
As well as ActiPatch therapy, BioElectronics offers RecoveryRx Devices for chronic and post-operative wound care and Allay Menstrual Pain Therapy.