ActiPatch Safety: Precautions and Contraindications
By Electrome Corporation · Published September 26, 2026
ActiPatch® is a nonthermal, sub-sensory wearable for FDA 510(k) cleared (K192234) over-the-counter (OTC) adjunctive treatment of musculoskeletal pain. Nonthermal and drug-free describe how the device operates; they do not remove the need to read its contraindications and package instructions or to seek care for concerning symptoms.
Who should not use ActiPatch?
Do not use ActiPatch if you have a pacemaker or an implanted cardioverter-defibrillator (ICD). Do not use it with another implanted electronic device. Do not use ActiPatch if you are pregnant or think you may be pregnant. These restrictions deserve attention even if you intend to wear the loop over clothing or far from an implant. When a medical history is unclear, ask your healthcare professional before use.
Keep the device away from the eyes. Seek a clinician’s guidance for undiagnosed pain. The current package insert is the controlling source for complete warnings, contraindications and instructions; read it before using the device rather than treating any website summary as an exhaustive replacement.
What does nonthermal or sub-sensory mean?
The device emits pulsed shortwave therapy at a 27.12 MHz carrier frequency at an output designed not to heat tissue. It does not use the adhesive electrodes or directly felt electrical stimulation associated with many TENS products. Users should not expect warmth or tingling as a signal that the device is operating. Instead, follow the package instructions for its indicator light and use.
Lack of a felt sensation is not the same as an absence of all potential discomfort. Attachment tape, a wrap or an awkward position may feel uncomfortable even though the emitted field is sub-sensory. If securing materials irritate your skin, remove them and consult the instructions or a healthcare professional about alternatives.
What do the clinical publications report about safety?
The safety summary is limited to this observation: no serious adverse events reported in the cited clinical studies. This statement refers to reporting in the cited literature, not a promise about every possible use or every future user. Studies enroll particular participants for defined periods, and an absence of a reported serious event in a study does not establish that problems cannot occur outside it.
Bagnato and colleagues’ Rheumatology 2016 randomized trial examined pain outcomes in knee osteoarthritis, and Brook and colleagues’ Journal of Foot and Ankle Surgery 2012 placebo-controlled study examined heel pain associated with plantar fasciitis. Read the original papers and our evidence summary to distinguish study observations from device labeling. Neither trial establishes that the device addresses the underlying diagnosis.
What daily-use precautions matter?
Keep ActiPatch dry; it is not waterproof and should be removed before bathing, showering or swimming. Secure the loop over the musculoskeletal pain area directly on skin with included tape or a wrap, or over a thin clothing layer. Avoid thick fabric. Do not modify the loop, casing or integrated CR2032 battery. A device provides 720 therapy hours and is intended for one user.
If the loop shifts during work, exercise or sleep, reposition it according to the insert. Do not wear it over damaged skin unless the package directions and your clinician permit that placement. If the device appears damaged, stop and check the directions or contact support instead of attempting to repair it.
When should you stop or contact a clinician?
If pain persists or worsens over the first several days, discontinue and seek medical advice. New, unexplained, severe or changing symptoms deserve assessment. Seek prompt care for red flags such as loss of strength, fever, sudden severe pain, or pain after a serious injury. A wearable should not delay evaluation of a condition that may require a different response.
ActiPatch is an adjunctive option for musculoskeletal pain relief, not a replacement for prescribed care or medicines. Consult your healthcare professional before changing existing treatment. The product page provides the current purchase details; our usage guide explains placement and daily care. For the regulatory indication, consult the FDA 510(k) record K192234.
Frequently asked questions
Can I use ActiPatch with a pacemaker or ICD?
No. Do not use it with a pacemaker, ICD or another implanted electronic device. Consult your clinician if you have questions about a medical implant.
Can I use it while pregnant?
No. Do not use ActiPatch if you are pregnant or think you may be pregnant.
Does not feeling anything mean the device is off?
Not necessarily. ActiPatch is designed to operate without perceived heat or tingling. Check its operating indicator as described in the package insert.
Were serious adverse events reported in the cited studies?
No serious adverse events reported in the cited clinical studies. That observation does not mean every individual will have the same experience; read the full precautions before use.
Primary sources
Educational information only. ActiPatch is FDA 510(k) cleared (K192234) for over-the-counter (OTC) adjunctive treatment of musculoskeletal pain. Read the package instructions and consult a clinician about persistent or worsening pain.