What the published research
actually says.
We hold ourselves to the language the evidence supports. PSWT is supported by peer-reviewed clinical research. ActiPatch is FDA-cleared (510(k) K192234) for over-the-counter adjunctive treatment of musculoskeletal pain; it can be used alongside other treatments.
Highlighted findings
Of patients stopped analgesics entirely in a double-blind, sham-controlled knee osteoarthritis RCT (Bagnato et al., Rheumatology 2016), with significant pain and function gains at one month and no adverse events.
Significant reduction in first-step morning heel pain in a double-blind, placebo-controlled plantar fasciitis trial (Brook et al., J Foot Ankle Surg 2012).
Mean pain reduction among the 65% of responders in a self-reported UK registry of 5,000+ patients (Rawe & Kotak, Pain Management 2015); 93% still relieved at three months.
Of peer-reviewed pulsed shortwave and PEMF literature spanning multiple indications.
Arresting spirochetes: nonthermal extremely low-frequency electromagnetic field exposure suppresses Borrelia burgdorferi motility in vitro
This preclinical in-vitro result does not establish a Lyme disease treatment, cure, clinical efficacy, or use in people. No Electrome product is cleared or marketed for Lyme disease or any infectious condition.
Open the preclinical research record510(k) documentation
Electrome's commercial PSWT infrastructure is built on two FDA 510(k) cleared devices operating at 27.12 MHz within the Industrial, Scientific, and Medical (ISM) radiofrequency band — ActiPatch®over-the-counter (OTC) and RecoveryRx® (clinician-directed) — developed and manufactured by BioElectronics Corporation and marketed by Electrome under an exclusive license.
FDA 510(k) cleared over-the-counter (OTC) pulsed shortwave therapy device for adjunctive treatment of musculoskeletal pain, including neck pain, knee osteoarthritis, and plantar fasciitis heel pain.
FDA listed shortwave diathermy device for use other than applying therapeutic deep heat. Wearable PSWT system utilizing low voltage electronics for clinician directed adjunctive therapy for postoperative pain and the reduction of postoperative edema in superficial soft tissue.
Published literature, by area
Findings vary by indication, device architecture, treatment parameters, and patient population. Electrome maintains an evidence aware and indication specific approach.
A double-blind, placebo-controlled trial reported significant improvements in pain and function at one month, with no adverse events reported in the study.
PubMedPulsed electromagnetic field therapy following surgery was associated with reductions in postsurgical pain, analgesic use, wound exudate, and edema within the studied population.
PubMedA recent pilot study of pulsed shortwave therapy for postoperative pain did not demonstrate statistically significant reductions in pain scores or opioid consumption within the evaluated populations. Variability across PEMF studies underscores the importance of indication, device, and protocol specificity.
PubMedPipeline and research initiatives
Electrome is exploring research initiatives in the areas below. These are research only; no efficacy claims are made.
Frequently asked
FDA-cleared means the FDA has cleared the device for a specific intended use through the 510(k) pathway, the standard regulatory pathway for devices in this category. ActiPatch® is FDA-cleared (510(k) K192234) for over-the-counter adjunctive treatment of musculoskeletal pain and can be used alongside other treatments. RecoveryRx® is cleared separately (K190251), for clinician-directed use, for adjunctive treatment of postoperative pain. Both clearance records are public in the FDA 510(k) database.
The strongest controlled evidence comes from two double-blind, placebo/sham-controlled trials: a knee osteoarthritis RCT (Bagnato et al., Rheumatology 2016) reporting significant pain and function gains at one month, with 26% of patients stopping analgesics entirely and no adverse events; and a plantar fasciitis trial (Brook et al., J Foot Ankle Surg 2012) showing a significant reduction in first-step morning heel pain. A UK real-world registry of over 5,000 patients (Rawe & Kotak, Pain Management 2015) additionally reported, on a self-reported basis, a 57% mean pain reduction among the 65% who responded, with 93% still relieved at three months.
No. TENS uses electrical current delivered through electrodes on the skin and produces a noticeable sensation. PSWT uses a nonthermal electromagnetic field at 27.12 MHz. A self-contained wearable—no electrode pads or lead wires to manage. Designed to operate without perceptible heat or tingling from the device.
No. Electrome does not market PSWT as an opioid replacement. PSWT is cleared for adjunctive treatment of specific pain conditions. Care decisions remain with the patient and provider.
The double-blind, controlled evidence is specific to knee osteoarthritis (Bagnato 2016) and plantar fasciitis (Brook 2012), with a head-to-head comparison against NSAIDs in neck osteoarthritis. Broader chronic-pain outcomes come from the Rawe & Kotak 2015 UK registry, which is self-reported real-world data rather than a randomized controlled trial and should always be read as such.
The ActiPatch® and RecoveryRx® devices are designed and manufactured by BioElectronics Corporation (BIEL), a trusted partner with decades of bioelectric research and development. BIEL has sold millions of devices worldwide under the ActiPatch® and RecoveryRx® brands, backed by a history of FDA clearances and CE marking, and is publicly traded (OTC: BIEL). Electrome markets and sells these devices in the United States under an exclusive license.