US-based electroceutical devices firm BioElectronics has received the US Food and Drug Administration (FDA) 510(k) approval for its drug-free ActiPatch medical device.
BioElectronics said that the FDA has granted the marketing approval for ActiPatch device, as an over-the-counter adjunctive treatment of musculoskeletal pain.
BioElectronics president Kelly Whelan said: “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.
“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.”
In 2017, BioElectronics obtained FDA approval for its ActiPatch, indicated as over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis.
The medical devices manufacturer said that the current regulatory approval would expand the indications of ActiPatch, to include all types of musculoskeletal pains.
ActiPatch deploys electromagnetic pulse therapy to treat chronic pain
ActiPatch is said to offer long-term chronic pain relief, by deploying electromagnetic pulse therapy and works against back pain, knee pain, muscle and joint pain, arthritis, sciatica, fibromyalgia, strains, and sprains.
In addition, ActiPatch has been designed as a drug and ingredient-free therapy, ensuring safe continuous use and can be used while under any other medication.
BioElectronics is a manufacturer of non-invasive electroceuticals, which offers a family of disposable, drug-free, pain therapy devices.
In addition to the ActiPatch therapy, the company offers RecoveryRx Devices for chronic and post-operative wound care, Allay Menstrual Pain Therapy, HealFast Veterinary Pain Relief, and Smart Insole Heel Pain Relief.
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.”
