PEMF therapy marketing rules: FDA and FTC

Pulsed electromagnetic field therapy, usually sold as PEMF, turns up in chiropractic offices, physical therapy and sports medicine clinics, pain clinics and wellness studios with mats or chairs. The ads often go further than the devices do: “heals injuries twice as fast,” “repairs cells at the source,” “reverses arthritis,” “FDA approved for depression, sleep and inflammation.” PEMF is not one thing in FDA’s eyes. Several product codes and regulations cover devices that use pulsed electromagnetic energy, each with its own indications, and those indications are narrower than most PEMF marketing.

This guide walks through the FDA codes we found, what sample clearances say a device is for, where the general wellness policy fits, and how FDA and FTC rules apply to pain, healing and disease claims, reviews and packages. We do not name any device, brand or company. For acoustic wave devices, see our guide to shockwave therapy clinic marketing. Vibration platforms are covered in our guide to whole body vibration marketing claims.

This is general information, not legal or medical advice. Sources cited were checked on November 1, 2026: FDA product classification, 510(k) and PMA data read through openFDA (device data last updated October 19, 2026); FDA’s 510(k) decision documents for K152432 (February 3, 2017), K192234 (January 31, 2020), K241395 (December 18, 2024) and K250309 (August 7, 2025); 21 CFR 890.5290, 890.5870, 882.5890, 807.97, 16 CFR 255.2 and 233.1 in the eCFR version as of October 29, 2026; FDA’s guidance General Wellness: Policy for Low Risk Devices (issued January 6, 2026); 21 USC 396 and 15 USC 45, 52 and 55 in the Cornell LII text of the U.S. Code; and the FTC Health Products Compliance Guidance (December 2022). We did not review the medical literature on PEMF, ad platform policies, or state rules on who may operate these devices.

The short version

Know your code. PEMF devices sit under different FDA product codes, from prescription postoperative pain devices to over-the-counter pain devices to bone growth stimulators. What you may say depends on which one your device was cleared or approved under.
Pain, mostly adjunctive. The clearances we read are for pain, usually as an adjunctive treatment, and several are prescription only.
Healing is a separate category. Bone growth stimulation has its own regulation for specific fracture and fusion uses. FDA lists a separate Class III code for PEMF to aid wound healing, and openFDA returned no clearance or approval under it.
Use the right word. A 510(k) clearance is not approval (21 CFR 807.97). “FDA approved PEMF” is wrong for a cleared device.
FTC rules apply to every claim. Healing speed, cell repair, inflammation and disease claims need competent and reliable scientific evidence.

The FDA codes behind PEMF devices

A search of FDA’s classification records through openFDA (device data last updated October 19, 2026) turned up these codes for devices that use pulsed electromagnetic or magnetic energy:

21 CFR 890.5290(b), nonthermal shortwave therapy (product code ILX). The regulation describes a prescription device that applies pulsed electromagnetic energy at 13.56 or 27.12 MHz for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue, by means other than deep heat. It is Class II with special controls, including labeling that gives recommended treatment regimes and a summary of the clinical testing and adverse events. openFDA lists 15 510(k) decisions under ILX.
Product code PQY, under the same regulation. Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain. openFDA lists two 510(k) decisions under it.
Product code QPL, under 21 CFR 882.5890. A device intended to apply a magnetic-field induced electrical current to treat pain, listed under the regulation for transcutaneous electrical nerve stimulators for pain relief. openFDA lists six 510(k) decisions under it, the earliest from June 2021.
21 CFR 890.5870, non-invasive bone growth stimulator (product code LOF). A prescription device that provides stimulation through electrical, magnetic or ultrasonic fields, used externally to promote bone formation as an adjunct to fracture fixation and spinal fusion or to treat established nonunions or failed fusions. FDA moved it to Class II with special controls in a final rule published April 16, 2026 (91 FR 20362). openFDA lists 177 PMA records, including supplements, under LOF.
Product code MBQ, peripheral electromagnetic field to aid wound healing. Listed as Class III with no regulation number. openFDA returned no 510(k) or PMA records under it.

Separately, product code SGT covers a non-medical device that uses a time-varying magnetic field to stimulate healthy muscles, which FDA describes as not intended for patients with medical conditions. That is the body contouring market, covered in our guide to body contouring clinic marketing.

What sample clearances actually say

Reading the indications for use in a few 510(k) decisions shows how specific they are:

K152432 (February 3, 2017, product code PQY). Adjunctive treatment of musculoskeletal pain related to plantar fasciitis of the heel and osteoarthritis of the knee.
K192234 (January 31, 2020, PQY). Expanded the over-the-counter indication to adjunctive treatment of musculoskeletal pain. The summary describes a study showing that lay users understood the indications and when not to use the device.
K241395 (December 18, 2024, ILX and two other codes). Adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains and arthritis. Prescription use only.
K250309 (August 7, 2025, QPL). Stimulation of peripheral nerves for relief of chronic intractable pain, post-traumatic pain, post-surgical pain and chronic painful diabetic peripheral neuropathy in the lower extremities, for patients 18 and older. Prescription use only.

Words like “adjunctive,” “temporary,” “palliative” and an age limit are part of the clearance. None of these indications mentions faster healing, tissue or cell repair, inflammation as a disease, depression, sleep, or any other condition outside pain. If you do not know which clearance covers the device in your office, ask the manufacturer for the K number and read its indications in FDA’s 510(k) database.

“FDA cleared” versus “FDA approved”

21 CFR 807.97 says a 510(k) clearance does not in any way denote official approval of a device, and that any representation creating that impression is misleading and constitutes misbranding. Most PEMF devices in the codes above reached the market through 510(k), so “FDA approved” is the wrong word for them. Bone growth stimulators approved through PMA before 2026 were approved; check the record for your device.

Wording that fits the record:

“FDA-cleared PEMF device for adjunctive relief of musculoskeletal pain” (for a device whose clearance says that).
“Prescription PEMF therapy cleared for the temporary relief of pain from strains, sprains and arthritis, used alongside your treatment plan.”

Wording that does not:

“FDA approved PEMF” for a cleared device.
“FDA cleared to heal fractures” for a pain device, or “FDA cleared for depression, sleep and inflammation” when the clearance says pain.
“FDA cleared” for a wellness mat that has no 510(k) at all.

Under 21 USC 396, a clinician may use a legally marketed device as they judge best for a patient, but the law says this “shall not change any existing prohibition on the promotion of unapproved uses.” Treating a patient off-label is a clinical decision; advertising that use is a different act. Our guide to medical device marketing claims covers clearance and off-label wording across specialties.

Wellness mats and the general wellness policy

Some PEMF mats and pads are sold for home or studio use without any FDA clearance, as general wellness products. FDA’s guidance General Wellness: Policy for Low Risk Devices (issued January 6, 2026) covers low-risk products whose intended use is limited to general wellness, such as relaxation or stress management, physical fitness and sleep management, without reference to disease. If a product’s intended uses go beyond those categories, the guidance says it does not apply, and it says that falling under the policy does not establish that a product has been shown to be safe or effective.

For a studio, that means a mat sold for relaxation can be described as a relaxing session. Once the ad says the same mat treats arthritis, depression, neuropathy or injuries, it is making disease claims outside the wellness policy, for a product with no clearance behind them. Our guide to cryotherapy and red light marketing claims covers the wellness policy for other studio equipment.

Pain, healing and disease claims under FTC rules

Section 5 of the FTC Act declares unfair or deceptive acts or practices unlawful (15 USC 45(a)), and section 12 makes it unlawful to disseminate a false advertisement to induce the purchase of devices or services (15 USC 52). The FTC Health Products Compliance Guidance says health claims need competent and reliable scientific evidence and that the FTC reads an ad for its net impression. An FDA clearance for one indication does not substantiate claims beyond it.

PEMF claims that need that support:

Healing speed. “Heals injuries twice as fast” or “recover in half the time” is a quantified claim that needs evidence for your device, your protocol and the condition named.
Cell and tissue claims. “Recharges your cells,” “repairs tissue at the source” and “increases cellular energy” are objective claims about what happens in the body.
Disease claims. Arthritis reversal, neuropathy cures, depression, insomnia, fibromyalgia and “inflammation” as a cause of disease all go beyond the pain clearances we read.
Bone and wound healing. These have their own FDA categories. A pain device advertised to mend fractures or heal wounds is promoted outside its clearance.
Safety. “Completely safe for everyone” conflicts with labeling that the special controls require to include adverse events and complications (21 CFR 890.5290(b)(2)(v)).

Leaving facts out can mislead too. Under 15 USC 55(a)(1), whether an ad is misleading depends partly on what it fails to reveal. If the device is for adjunctive use, if it needs repeated sessions, or if the labeling lists people who should not use it, say so near the price and the booking button.

Reviews, testimonials and results

Under 16 CFR 255.2(a), an advertiser must have substantiation for what a consumer endorsement conveys, as if it made the claim itself. A featured review saying “PEMF healed my torn rotator cuff in three weeks” carries a healing claim the practice would need to support. Under 16 CFR 255.2(b), an endorsement about a central attribute is likely to be read as showing typical results unless the ad clearly and conspicuously discloses the generally expected results.

Many PEMF patients also receive other care at the same visit, such as adjustments, exercise or medication. Do not let a review credit PEMF with an outcome from the whole plan. See our guide to patient testimonials and before-and-after photos.

Packages, memberships and prices

Say what a session is. Length, device type (prescription clinic device or wellness mat), body area and how many sessions your protocol uses.
Packages need plain terms. Number of sessions, expiry, refund terms and whether a clinician sees the patient first.
Former prices must be real. “Was $1,200, now $699” needs a former price you actually offered in good faith for a reasonably substantial period (16 CFR 233.1(a)).
Do not imply insurance coverage unless you have checked it for the patient’s plan.

See our guides to advertising cash prices and money-back guarantees in healthcare ads.

An example (made up)

This illustration is invented. A clinic posts: “FDA approved PEMF! Heals sprains, fractures and arthritis 2x faster by recharging your cells. Also helps depression, insomnia and neuropathy. Safe for everyone. 10 sessions, was $1,500, now $599.”

Fixes: “FDA approved” becomes “FDA cleared” with the device’s actual indication, for example adjunctive temporary relief of pain from strains, sprains and arthritis. “Heals fractures” comes off unless the device is a bone growth stimulator used for its approved or cleared purpose. “2x faster” and “recharging your cells” come off unless the clinic holds competent and reliable scientific evidence. Depression and insomnia come off. Neuropathy stays only if the device’s clearance covers it, worded as the clearance words it, with the age limit. “Safe for everyone” becomes a short note on who should not use it. The former price stays only if patients actually paid $1,500 for a reasonable period.

Checklist

Know the product code and K or PMA number behind each PEMF device you use, and read its indications.
Cleared and approved used correctly; no “FDA approved” for a cleared device (21 CFR 807.97).
Claims match the indication: pain, adjunctive, temporary, prescription or OTC, age limits.
No promotion of unapproved uses such as fracture, wound, depression or sleep claims for a pain device (21 USC 396).
Wellness mats described only within the general wellness policy, without disease claims (FDA guidance, January 6, 2026).
Healing speed, cell, inflammation and disease claims backed by competent and reliable scientific evidence, or removed (15 USC 45, 52; FTC guidance).
Session counts, adjunctive use and who should not use it stated where the service is sold (15 USC 55(a)(1)).
Reviews do not say what the practice could not say; typical results disclosed (16 CFR 255.2).
Prices, packages and former prices are real and clear (16 CFR 233.1).

How we help

We build service pages for chiropractic, physical therapy, pain and sports medicine practices with claims checked against the sources above: website design, healthcare SEO for searches like “PEMF therapy near me,” and lead generation campaigns that describe PEMF within its clearance. We do not decide whether a treatment works, we do not give legal opinions, and we are not a law firm. Related guides: pain management clinic marketing, sports medicine practice marketing and chiropractic marketing ideas.

Is PEMF therapy FDA approved?

Most PEMF devices we found reached the market through 510(k) clearance, which 21 CFR 807.97 says does not denote approval. Bone growth stimulators were approved through PMA before FDA moved them to Class II in April 2026. Check the record for your own device and use the word that matches it.

What can we say PEMF treats?

What your device’s clearance says. The clearances we read are for pain, often adjunctive or temporary, such as musculoskeletal pain or pain from strains, sprains and arthritis, and some are prescription only or limited to adults. Bone growth and wound healing have separate FDA categories.

Can we say PEMF speeds up healing?

Only with competent and reliable scientific evidence for that claim, your device and the condition named. None of the pain clearances we read mentions faster healing, and a pain device advertised for fractures or wounds is promoted outside its clearance.

Our studio uses a wellness PEMF mat with no FDA clearance. What can we say?

Relaxation and similar general wellness claims without reference to disease, under FDA’s general wellness guidance (January 6, 2026). Disease claims such as arthritis, neuropathy or depression fall outside that policy, and the FTC requires evidence for any health claim.

Can we post a review saying PEMF healed an injury?

Not in your ads unless you could support that claim yourself. Under 16 CFR 255.2, the practice needs substantiation for what a featured endorsement conveys, and central results are likely to be read as typical.

Sources

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PEMF therapy marketing: cleared indications vs pain, healing and disease claims