ActiPatch® Safety: Precautions and Contraindications
By Electrome Corporation · Published September 26, 2026
ActiPatch® is a nonthermal, sub-sensory wearable. That means it does not heat the skin and you should not feel it. It is FDA 510(k) cleared (K192234) for over-the-counter (OTC) adjunctive treatment of musculoskeletal pain. Nonthermal and drug-free describe how it works. You still need to read the contraindications and package instructions, and to get care for worrying symptoms.
Check before you wear
- Implant or pacemaker?Do not use it with an implanted electronic device.
- Pregnant?Do not use it if you are or may be pregnant.
- Pain new or unexplained?See a clinician first.
- Skin or tape trouble?Remove the tape and read the insert.
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 it if you are pregnant or think you may be pregnant. These limits apply even if you wear the loop over clothing or far from an implant. If your medical history is unclear, ask your healthcare professional first.
Keep the device away from your eyes. Get a clinician’s advice for pain with no diagnosis. The current package insert is the main source for full warnings, contraindications, and instructions. Read it before use. Do not treat a website summary as a full replacement.
What does nonthermal or sub-sensory mean?
ActiPatch® uses pulsed shortwave therapy at a 27.12 MHz carrier frequency, at an output designed not to heat tissue. It does not use adhesive electrodes or the felt electrical stimulation of many TENS products. Do not expect warmth or tingling to show it is working. Follow the package instructions for the indicator light and use.
Feeling nothing does not mean nothing can be uncomfortable. Tape, a wrap, or an awkward position may still feel uncomfortable even though the field itself is sub-sensory. If the securing materials irritate your skin, take them off and check the instructions or ask a healthcare professional about alternatives.
What do the clinical publications report about safety?
No serious adverse events were reported in the cited clinical studies of ActiPatch®. That covers what those studies recorded for their own participants over set periods. It is not a promise of safety for every use or person. Tape or a wrap can still irritate skin, so follow the package warnings and contraindications.
Bagnato and colleagues’ Rheumatology 2016 randomized trial looked at pain in knee osteoarthritis. Brook and colleagues’ Journal of Foot and Ankle Surgery 2012 placebo-controlled study looked at heel pain linked to plantar fasciitis. Read the original papers and our evidence summary to tell study findings from device labeling. Neither trial shows that the device treats the underlying diagnosis.
What daily-use precautions matter?
ActiPatch® is made for everyday wear, including activity and sweating, with IP22-rated water protection. Remove it before bathing, showering, or swimming. Put the loop over the painful area on skin with the included tape or a wrap, or over a thin layer of clothing. Avoid thick fabric. Do not modify the loop, casing, or built-in CR2032 battery. A device provides up to 720 therapy hours and is for one user.
If the loop shifts during work, exercise, or sleep, reposition it using the insert. Do not wear it over damaged skin unless the package directions and your clinician allow it. If the device looks damaged, stop and check the directions or contact support. Do not try to repair it.
When should you stop or contact a clinician?
If pain lasts or gets worse over the first several days, stop and get medical advice. New, unexplained, severe, or changing symptoms need assessment. Get prompt care for warning signs such as loss of strength, fever, sudden severe pain, or pain after a serious injury. A wearable should not delay checking a problem that may need a different response.
ActiPatch® is an adjunctive option for musculoskeletal pain relief. It does not replace prescribed care or medicines. Ask your healthcare professional before changing existing treatment. The product page has current purchase details, and our usage guide explains placement and daily care. For the cleared use, see 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.