StemWave therapy: what it is, what it's listed for, and how we use it

StemWave therapy uses a focused acoustic wave device: an applicator moved over the skin delivers pulses into the tissue underneath. We added it at our Clarksville practice in September 2026, and we use it alongside other care for selected muscle and joint complaints. We offer it, so here's how we think about it.

Is StemWave FDA approved?

No. StemWave isn't FDA approved and it isn't FDA cleared. The manufacturer's regulatory statement describes the device as a Class I therapeutic massager that is exempt from FDA premarket notification, intended for the temporary relief of minor muscle aches and pains and a temporary increase in local blood circulation. It says the manufacturer is registered with the FDA and the device is listed, and adds, in its own words, that "Registration and listing do not denote FDA approval or clearance." That's the intended use its regulatory statement gives.

Class I is the lowest-risk of the FDA's three device classes, and most Class I devices are exempt from premarket review. The FDA says registration and listing tell it where device makers are and what they make. They don't mean the FDA has reviewed evidence that the device is safe or effective for anything.

The manufacturer describes the device as delivering focused pulses of mechanical energy without relying on heat, and describes how tissue responds to mechanical load. Its own site says those mechanistic descriptions are not statements of intended use and are not claims about diagnosing, treating, curing or preventing any condition. We read it the same way.

Is StemWave the same as shockwave therapy or SoftWave?

People search for StemWave and shockwave therapy together, and its maker puts it in the shockwave family. In the video above, the manufacturer says StemWave works by creating a spark in water, which sends acoustic waves into the tissue, and its chart of device types labels it "StemWave Shockwave" beside electromagnetic, piezoelectric and radial pressure shockwave. Those labels name how each type makes its wave. The video's comparisons with other devices are the manufacturer's own, and we haven't seen them tested.

"Shockwave" gets used for a lot of different devices, and the FDA lists them differently. The FDA has a product code for a shock wave generator for pain relief, which is Class III, the class that needs premarket approval. The manufacturer says StemWave is listed under a different code, as a Class I therapeutic massager. That's a difference between those two listings. It doesn't tell you how StemWave compares with every device sold as shockwave therapy.

Published research uses the term extracorporeal shock wave therapy, or ESWT, for a family of devices, including extracorporeal and radial types used at higher and lower doses. We searched PubMed for studies of StemWave by name in October 2026 and found none. So the research on this page is about shockwave devices, not StemWave, and it doesn't tell you what StemWave does.

SoftWave is a different company's device. Ours is StemWave. SoftWave's own clearance page lists a general use much like StemWave's, relief of minor muscle aches and pains and a temporary increase in local blood circulation, along with activation of connective tissue. It also lists FDA-cleared uses for certain diabetic foot ulcers and second-degree burns, which aren't conditions we treat. StemWave has no FDA-cleared use. Neither listing tells you that one device does more than the other for a sore shoulder or heel.

Does StemWave use stem cells?

No. Nothing is taken from your body and nothing is injected, so no stem cells are added, your own or anyone else's. The name makes people think of stem cell injections, but the manufacturer doesn't say the device makes stem cells. Its home, patient and science pages and the video above don't mention stem cells at all.

You may hear that it draws your own stem cells to the area. The research we found behind that idea is in cells and animals. In lab dishes, shock waves made three kinds of cells multiply, including human stem cells taken from fat tissue, and in rats they improved wound healing (Weihs and colleagues, 2014). When we searched PubMed in October 2026, 220 records mentioned shock waves and stem cells together. PubMed tags four of them as clinical trials, and none of those four measured whether shock waves made stem cells in a patient.

So this page doesn't say StemWave grows new stem cells, and it doesn't offer StemWave as a cheaper version of a stem cell injection. The FDA says stem cell products, whether taken from your own body or another person's, are among the regenerative medicine therapies that have not been approved to treat any orthopedic condition, and it names tendonitis, back pain, knee pain and shoulder pain among those conditions.

How do we use StemWave at Source Chiropractic?

We use StemWave on the plantar fascia as one part of care for plantar fasciitis and heel pain. The device's listed use, minor muscle aches and pains, doesn't name plantar fasciitis or any other diagnosis. One of our chiropractors may also add it to a plan for muscle and joint complaints involving the shoulder, the low back, the knee, the elbow, or the wrist and hand. For pain running down the leg, it's usually not part of care, and our sciatica page covers what is.

It's something we add to a plan, not a plan on its own. A history and an examination come first, and the exam is what tells us if an acoustic wave device has anything to offer for what we find.

What is a StemWave session like?

A session is short. We put gel on the skin over the area and move the applicator across it while the device delivers pulses. Nothing is injected and no anesthetic is used. The number of sessions, if any, is decided after the exam and reviewed against your progress. It isn't set in advance from a brochure.

How much does StemWave cost?

We don't list a StemWave price on this page. The new-patient chiropractic offer has its own terms, and that page says to ask what is included in your visit and what any additional services would cost. The same goes for StemWave: what each session costs, how many we expect, and when we'll review whether it's helping.

What don't we use StemWave for?

We don't use StemWave to diagnose anything, and we don't use it in place of an evaluation when symptoms are new, worsening, or unexplained. It isn't a treatment for fractures, infections, tumors, inflammatory arthritis, or any condition outside the musculoskeletal scope of a chiropractic physician. Those we refer.

Before a first session, we need to know if you're pregnant, take blood-thinning medication or have a bleeding disorder, have an implanted electronic device, or have had a steroid injection in the area recently. The same goes for numbness, an open wound or a skin condition where we'd be working. We need each of those facts before we decide, and sometimes the answer is that the device isn't right for you.

What are the side effects and risks?

The research here is on shockwave devices, not StemWave. In a systematic review of 39 plantar fasciitis studies, covering 2,493 patients and roughly 6,400 treatment sessions, 225 patients reported pain during treatment and 247 reported transient red skin afterwards. Transient pain after treatment, swelling, bruising and altered sensation were also reported, and two complications occurred: chest pain, and a superficial skin infection after a regional anaesthetic. Its authors concluded shock wave therapy is likely safe for plantar fasciitis, with no complications expected at one year, and that long-term complications are unknown. In a 2020 Cochrane review of 32 trials of shock wave therapy for rotator cuff disease, five trials counted adverse events: 41 of 156 people with treatment against 10 of 139 with placebo. The authors rated that evidence low quality, said the rates may not truly differ, and concluded that the safety of shock wave therapy is uncertain. Both reviews are in the research below.

Two caveats go with those numbers. They come from trials of other devices, so they don't tell you what StemWave does. And as we said above, a Class I listing isn't an FDA safety review. If something bothers you during or after a session, we want to know.

What are the alternatives to StemWave therapy?

It depends on the diagnosis. For the three complaints below, the options the guidelines and trials put first are advice, exercise and footwear.

• Shoulder and rotator cuff pain. In a large 2021 trial, a progressive exercise programme of up to six sessions was not superior over a year to a single session of best-practice advice, and corticosteroid injection gave no long-term benefit (see the research on shoulder pain).
• Plantar heel pain. The NHS lists supportive shoes, insoles and stretching exercises first, with shock wave therapy among the options if those don't help. The review below found that custom orthotics improved function more than shock wave therapy, and that platelet-rich plasma injection did better than it for pain and function, though it's a more involved procedure. Our plantar heel pain page goes through the other things we use for it.
• Low back pain. NICE, which writes the clinical guidelines for England's NHS, recommends staying active, and suggests considering exercise, with manual therapy only as part of an exercise-based plan. The review below is of shock wave devices, not StemWave, in chronic low back pain. Fourteen trials measured pain and eight measured function, and shock wave therapy added to physical therapy did better than physical therapy alone on both. Its authors call for more high-quality trials before the finding is settled.

We also use laser therapy and dry needling as add-ons, each with its own page and its own limits, and a licensed massage therapist works out of our office; we'll put you in touch (more on massage therapy). Medical care and physical therapy meet different needs, and when what we find isn't ours to treat, we'll tell you and refer you.

How do we decide if StemWave belongs in your plan?

We start with what the exam finds. We'll go over what we found before we recommend anything, and the plan is built around your condition and your goals, so StemWave only goes in when it fits the finding. Once it's in, the number of sessions is reviewed against how you're doing, and if it isn't helping or something feels worse, we want to hear about it.

If we are not able to help you with your problem or are unable to reduce your pain levels, we will make sure to give you a recommendation to another experienced provider. If a friend or an ad got you wondering about StemWave, that's a good thing to ask about at a first visit, and the exam is how we'd answer it.