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 pulses with a time gap in between, regulating the electrical activity of the nervous system. PSWT is more useful in the treatment of muscle and nerve cell damage, reducing inflammation and improving the healing process.
ActiPatch is a small, lightweight, and noninvasive wearable medical device developed to offer long-term chronic pain relief through PSWT. Its electromagnetic signal pulses 1,000 times per second to modulate nerve activity and reduce pain.
The device is placed over the area of the body that is causing pain, attached with flexible circular wraps or medical tape, and activated through an on/off switch. Its activity is sensation-free, with no feel of heat or vibration. Since it was designed as a medication- and ingredient-free musculoskeletal pain therapy, it allows safe continuous use with any other medication.
Data from clinical trials and a seven-day trial user registry study (which included fibromyalgia patients) showed that ActiPatch effectively relieved chronic pain and influenced pain threshold, while reducing medication use (including opioids) and improving physical functioning, sleep, and quality of life.
According to the company, ActiPatch works against back pain, knee pain, muscle and joint pain, arthritis, sciatica, fibromyalgia, and muscle strains and sprains. It provides a total of 30 days of on and off therapy; since most users obtain pain relief with eight hours of daily use, it generally lasts several months.
A U.K. health economics study showed that three months of ActiPatch therapy helped users reduce visits to the doctor by about 50% and their medication costs by 37%, resulting in an overall 42% reduction in healthcare costs.
“The expanded clearance paves the way for new products to be marketed with approved medical claims for musculoskeletal pain in the back, knee, hips, wrists, elbow, ankle, etc.,” said Keith Nalepka, BioElectronics’ sales and marketing vice-president.