The Science of ActiPatch®

Drug-Free Pain Relief, Backed by Bioelectric Frontiers

ActiPatch® is an over-the-counter FDA-cleared device built on pulsed shortwave therapy, a nonthermal form of electromagnetic therapy used as an adjunct in the treatment of musculoskeletal pain. No drugs, no electrodes or gels. Wear directly on the skin with the included tape or a wrap, or over a thin layer of clothing; avoid thick fabric.

ActiPatch® is manufactured by BioElectronics Corporation (BIEL). Electrome holds the exclusive North American license.

Pulsed 27.12 MHz carrierBursts of RF energy, enlarged to show the carrier cycle
  • FDA-cleared technology
  • Non-opioid
  • No electrodes or gels
The Approach

A Bioelectric Approach to Pain Relief

ActiPatch® uses pulsed shortwave therapy (PSWT), a nonthermal form of pulsed electromagnetic field therapy. PSWT modulates cellular signaling associated with inflammation and pain, all without electrodes, gels, or any sensation during use.

The signal diagram at the top of this page is a schematic built from the 27.12 MHz carrier frequency. Burst spacing is drawn for clarity rather than to scale, and it shows how the signal is structured, not a measured patient response.

27.12 MHz Carrier

ActiPatch® uses a precisely tuned 27.12 MHz electromagnetic carrier in the Industrial, Scientific, and Medical band. The same frequency used in pulsed shortwave therapy research for decades.

Nonthermal Therapy

PSWT operates at energy levels below any thermal effect. There is no heat, no warming sensation, and no perceptible feedback during use. The therapy fits comfortably into daily wear.

No Electrodes or Gels

There are no electrodes, no gels, and no skin prep. Wear it directly on the skin with the included tape or over a thin layer of clothing.

FDA-Cleared Technology

ActiPatch® is FDA-cleared (510(k) K192234) for over-the-counter adjunctive treatment of musculoskeletal pain, including muscle and joint pain. It can be used alongside other treatments. No prescription needed.

Evidence Base

Clinical Literature, Summarized

Pulsed shortwave therapy is supported by decades of peer-reviewed research across multiple chronic pain indications. Below is a conservative summary of the published clinical literature relevant to ActiPatch®.

Knee osteoarthritis RCT

A double-blind, sham-controlled randomized trial in knee osteoarthritis (Bagnato et al., Rheumatology 2016) reported pain and function improvements in its study population. Its findings do not guarantee an individual result.

Plantar fasciitis trial

A double-blind, placebo-controlled trial in plantar fasciitis (Brook et al., J Foot Ankle Surg 2012) reported a significant reduction in first-step morning heel pain versus placebo.

Real-world registry

A UK chronic-pain registry (Rawe & Kotak, Pain Management 2015) describes self-reported outcomes. As an observational registry without a sham comparison, it cannot by itself establish a treatment effect.

Regulatory context

ActiPatch® is FDA-cleared (510(k) K192234) for over-the-counter adjunctive treatment of musculoskeletal pain and can be used alongside other treatments. We say "supported by clinical evidence" because that reflects what the published literature shows.

Evidence is not interchangeable across devices. The knee osteoarthritis and plantar fasciitis studies above should be read alongside their study designs and limitations; the registry relies on self-report without a sham control. These sources do not establish superiority over TENS. For source details, see the publications library and the knee osteoarthritis evidence hub.

Individual results may vary. ActiPatch® is intended for adjunctive use alongside your current care plan. Consult your healthcare provider before starting any new therapy.

Bioelectric Frontiers

How Pulsed Shortwave Therapy (PSWT) Differs from TENS

TENS and PSWT are fundamentally different therapeutic technologies that use different forms of energy delivery, treatment models, and clinical workflows. This comparison describes how they are used, not a head-to-head efficacy finding or a reason to replace prescribed care.

Read the full article, How Pulsed Shortwave Therapy (PSWT) Differs from TENS →

Quick Comparison

PSWT vs TENS at a glance

Energy Delivery
PSWT
Pulsed electromagnetic field
TENS
Electrical current
Skin Contact
PSWT
Directly on skin with included tape or wrap, or over thin clothing; avoid thick fabric
TENS
Adhesive electrodes required
Sensation
PSWT
No tingling sensation from the device
TENS
Tingling or buzzing sensation
Wear Duration
PSWT
Up to 720 therapy hours per device
TENS
Typically session based
Frequency Type
PSWT
Radiofrequency carrier (27.12 MHz)
TENS
Low frequency electrical stimulation
Therapy Model
PSWT
Continuous or prolonged exposure
TENS
Short duration stimulation sessions

Technology characteristics vary between manufacturers and device classes.

Broader Comparison

PSWT, TENS, NMES/EMS, and HFIT

Clearances are device specific. No technology class is cleared as a whole for one use, and no study here compares ActiPatch® head to head with NMES, EMS, or HFIT devices. This table describes design and labeling, not which works better.

Example FDA clearance and indication

ActiPatch® PSWT(Pulsed shortwave therapy)
K192234: over-the-counter adjunctive treatment of musculoskeletal pain.[4]
TENS(Transcutaneous electrical nerve stimulation)
Cleared device by device. ENSO K233784 TENS mode, for example, covers chronic intractable pain and temporary relief of sore, aching muscles.[1]
NMES / EMS(Neuromuscular / electrical muscle stimulation)
Muscle stimulator indications focus on muscle conditioning and rehab, such as relaxing spasms and preventing disuse atrophy (H-Wave K103738). Pain claims apply only if a specific device is cleared for them.[5][6]
HFIT (Enso)(Hinge Health branded term; see note)
No separate FDA category for HFIT. ENSO K233784 is cleared as OTC TENS plus a muscle stimulation mode for healthy muscles.[1]

Energy delivered

ActiPatch® PSWT(Pulsed shortwave therapy)
Pulsed 27.12 MHz electromagnetic field, nonthermal.[7]
TENS(Transcutaneous electrical nerve stimulation)
Electrical current through skin electrodes.[1]
NMES / EMS(Neuromuscular / electrical muscle stimulation)
Electrical current through electrodes that repeatedly contracts muscles.[8]
HFIT (Enso)(Hinge Health branded term; see note)
Electrical pulses; ENSO's 510(k) lists 40 to 160 Hz output.[1]

Intended sensation

ActiPatch® PSWT(Pulsed shortwave therapy)
No intended tingling or muscle contraction; the instructions state there is no sensation from the pulses.[9][10]
TENS(Transcutaneous electrical nerve stimulation)
Perceptible stimulation, adjusted by the user.[11]
NMES / EMS(Neuromuscular / electrical muscle stimulation)
Visible muscle contraction is the intended effect.[8]
HFIT (Enso)(Hinge Health branded term; see note)
User-adjusted intensity. We could not verify a published statement on whether it is felt, so we make no claim.[11]

Hardware

ActiPatch® PSWT(Pulsed shortwave therapy)
Self-contained, wire-free; no controller, app, or charging.[9]
TENS(Transcutaneous electrical nerve stimulation)
Varies: corded units with lead wires and wireless pods both exist; all use electrodes.[11][6]
NMES / EMS(Neuromuscular / electrical muscle stimulation)
Varies; H-Wave, for example, uses lead wires and self-adhesive electrodes.[6]
HFIT (Enso)(Hinge Health branded term; see note)
Small wireless unit controlled from the Hinge Health app.[11]

Wear model

ActiPatch® PSWT(Pulsed shortwave therapy)
Extended wear, up to 720 device hours; on skin with tape or wrap, or over thin clothing.[9][7]
TENS(Transcutaneous electrical nerve stimulation)
Typically session based; follow each device's instructions.[1]
NMES / EMS(Neuromuscular / electrical muscle stimulation)
Session based, often under clinician direction for rehab goals.[6]
HFIT (Enso)(Hinge Health branded term; see note)
Sessions guided within Hinge Health's digital program.[11]
About the term HFIT. HFIT is Hinge Health's branded name for Enso's waveform. Its published trial titles use two expansions: High-Frequency Impulse Therapy (2021 pilot) and Hybrid Form Impulse Therapy (2024 trial, which describes a priming pulse added to a traditional TENS pulse width and frequency). It is not an FDA device category. The published trials are sponsor-affiliated, involve only Hinge Health's device, and do not compare it with ActiPatch.[1][2][3]

Sources and what they support

  1. [1] ENSO (Model 2) K233784, 510(k) letter and indications FDA 510(k) summary / indications Hinge Health device cleared under the OTC TENS product code with a TENS mode and a muscle stimulation mode. Covers ENSO only.
  2. [2] Hong et al., J Pain Res 2024: Effectiveness of Hybrid Form Impulse Therapy (HFIT) Compared to Traditional Transcutaneous Electronic Nerve Stimulation (TENS) in Patients with Chronic Low Back and Knee Pain: A Randomized Controlled Trial Peer-reviewed study Sponsor-affiliated (Hinge Health) trial of its own device versus TENS. Does not involve ActiPatch®.
  3. [3] J Pain Res 2021: High-Frequency Impulse Therapy for Treatment of Chronic Back Pain: A Multicenter Randomized Controlled Pilot Study Peer-reviewed study Pilot-scale study of the HFIT device. Does not involve ActiPatch®.
  4. [4] ActiPatch® K192234, FDA 510(k) clearance record FDA 510(k) clearance record Database record of an FDA clearance, not a certificate. Covers ActiPatch® only.
  5. [5] FDA guidance, Powered Muscle Stimulator 510(k)s FDA guidance Lists standard indications a muscle stimulator may seek. Each device is cleared only for the indications in its own 510(k).
  6. [6] H-Wave K103738, FDA 510(k) clearance record FDA 510(k) clearance record Cleared as a powered muscle stimulator (Electronic Waveform Lab). Covers that device only.
  7. [7] ActiPatch® K192234, 510(k) summary FDA 510(k) summary / indications Lists 27.12 MHz carrier and battery life up to 720 hours for the largest model. Not a comparative efficacy finding.
  8. [8] 21 CFR 890.5850, Powered muscle stimulator Federal regulation Defines the device type. Does not clear any specific product.
  9. [9] BioElectronics ActiPatch® Directions for Use (Model 088, DFU-MULTI-ENG-303) Manufacturer instructions Official manufacturer instructions: 27.12 MHz carrier, operation time up to 720 hours, no sensation from the pulses, use through light clothing. Labeling, not a comparative efficacy finding.
  10. [10] BioElectronics ActiPatch® product page Manufacturer product page Manufacturer description of a sensation-free device. Marketing source, not a clinical endpoint.
  11. [11] Hinge Health Enso product page Manufacturer product page Describes Enso as small and wireless with app-controlled intensity. Marketing source.

Full citations live with the article: Primary references →

Informational use only. This page is not medical advice. ActiPatch® is FDA-cleared (510(k) K192234) for over-the-counter adjunctive treatment of musculoskeletal pain and can be used alongside other treatments. Individual experiences vary. Consult a qualified healthcare provider before starting any new therapy.

Designed for Daily Life

Designed for Everyday Pain, Recovery, and Movement

ActiPatch® was built to disappear into your routine. Wearable, drug-free, and continuously active for up to 720 hours per device.

Wearable

Lightweight and low profile, with up to 720 hours of therapy per device. Wear it continuously day and night, or in stretches with breaks, at rest or in motion.

Simple

Wear it and go, with nothing to connect or manage. Place it over the painful area, switch it on, and continue with your day.

Non-drug

Drug-free pain support that works alongside, not in place of, your current care plan. Talk with your provider about integrating ActiPatch® into your routine.

Ready to Try Drug-Free Pain Relief?

Put the science to work. ActiPatch® is FDA 510(k)-cleared, non-opioid, and built for flexible wear, continuously or as needed. It is available over-the-counter for adjunctive treatment of musculoskeletal pain, including heel pain associated with plantar fasciitis.