Shockwave vs. SoftWave & StemWave
SoftWave, StemWave And Focused Shockwave Are Not The Same Treatment
If you have been quoted a much lower price for something called SoftWave or StemWave, this page tells you what you are actually comparing — using each device’s own FDA paperwork and each manufacturer’s own published words, not marketing claims.
Start Here
What All Of These Machines Get Right
The Mechanism Is Real
Every one of these devices sends acoustic pressure waves into tissue, and the idea behind that is sound. Mechanical force applied to a stalled repair site can wake up blood supply and cell signalling. There are decades of published research behind the mechanism.
No Drugs, No Downtime, No Cutting
Nobody is cutting you, injecting you or putting you on medication. You walk in and you walk out the same day. Against the injection-and-surgery path, that is a real advantage — and it is true of all three machines.
A Lower Price Is A Real Advantage
If a clinic near you charges less, that counts for something and we are not going to pretend otherwise. The only question worth asking is what the lower number buys you. That is a question about the device and the clinician, not about who is friendlier on the phone.
We are not anti-SoftWave and we are not anti-StemWave. These are real devices doing real work, and some clients do well on them. The problem is that the three names get used as though they mean the same thing — and they do not.
The Difference That Matters
Three Machines, Three Different Levels Of FDA Review
This is the part almost nobody explains at the front desk, and it is not our opinion — it is public record. The FDA reviews devices at three very different levels of scrutiny, and these three machines sit on three different rungs.
Registered, Cleared, Approved — Three Different Words
Registration means the maker has told the FDA the device exists. StemWave’s own science page describes it as “registered with the U.S. Food and Drug Administration as a Class I therapeutic massager,” and adds, in its own words, that “FDA registration is not an FDA endorsement, approval, or clearance.”
Clearance (a 510(k)) means the FDA agrees the device closely resembles one already sold. SoftWave’s published list of clearances covers chronic diabetic foot ulcers, second-degree burns and “activation of connective tissue.”
Approval (a PMA) means the FDA examined the company’s own pivotal clinical trial. The focused device in our rooms, a Storz DUOLITH SD1 T-Top, holds one: premarket approval P080028 for chronic plantar fasciitis, granted on a 250-person randomised, double-blind, sham-controlled trial across five US sites. No unfocused device and no Class I registered device holds one.
How To Read A Clinic Website
One caveat that cuts our way as much as anyone’s: an FDA approval belongs to a specific device, not to a whole category. Ask any clinic — this one included — which exact make and model sits in the treatment room, then check that model’s own listing rather than taking the category on trust.
Ours, so you can go and check them yourself: a Storz DUOLITH SD1 T-Top ultra for focused shockwave, an OrthoPulse Ultra 100+ for radial, and a Storz MAGNETOLITH Plus for EMTT, cleared under 510(k) K203710. All three are listed in the FDA’s public databases under Storz Medical AG.
So when you are reading a clinic’s website, there is one comparison worth making: what is this device actually cleared or approved to treat, and is my problem on that list?
If the paperwork covers wound healing and minor muscle aches, and the sign in the window says knee arthritis, those are not the same claim. Treating beyond a cleared indication is perfectly legal for a licensed provider — it happens across medicine every day, and we do it too. But you are entitled to know that is what is happening, and to decide with that in front of you.
Side By Side
Focused Shockwave vs. SoftWave vs. StemWave
| Focused Shockwave (what we use) | SoftWave | StemWave | |
|---|---|---|---|
| Highest level of FDA review | PMA approval — P080028, held by the Storz DUOLITH SD1 T-Top platform in our treatment rooms | 510(k) clearance — Class II | Class I registration — not a clearance or an approval, per StemWave |
| What that paperwork covers | Heel pain from chronic proximal plantar fasciitis, in adults who have failed at least six months of conservative care — plus the same diabetic foot ulcer clearance SoftWave holds (K202112) | Chronic full-thickness diabetic foot ulcers up to 16 cm²; superficial partial-thickness second-degree burns; activation of connective tissue | Temporary relief of minor muscle and joint aches and pains |
| Clinical trial in its FDA file | Yes — 250 subjects, five US sites, randomised, double-blind, sham-controlled | Not required for a 510(k), which rests on similarity to an existing device | Not required for a Class I registration |
| Wave type, as the maker describes it | Focused | Unfocused / planar | Focused |
| Also available in the same visit | Radial shockwave (EPAT) and EMTT magnetotransduction, chosen by depth | Varies by clinic — ask | Varies by clinic — ask |
| Who operates it | A Doctor of Physical Therapy, board-certified in sports physical therapy | Varies by clinic — ask | Varies by clinic — ask |
Practical Answer
Three Questions Worth Asking Before You Pay Anyone
Including us. If a clinic cannot answer these in a sentence each, that tells you something on its own.
1
“What is this machine approved or cleared to treat?”
Not what it can be used for — what the paperwork says. Then ask whether your problem is on that list. It is a fair question and a short one, and the answer tells you how much of what you are about to hear is regulated fact and how much is enthusiasm.
2
“How deep does it reach, and how deep is my problem?”
A plantar fascia sits a few millimetres down. A gluteal tendon sits several centimetres down under a layer of muscle. A device that spreads its energy across the surface and a device that concentrates it on a point are solving different problems. If nobody has measured or examined where your pain is coming from, depth is being guessed at.
3
“Who is holding the applicator, and what happens after?”
The device provokes the repair. What makes the new tissue hold up is the loading work that follows, and that requires a diagnosis and a progression. Ask who is doing the assessment, what their licence is, and what the plan looks like after the machine is switched off.
Questions
SoftWave & StemWave FAQ
Is StemWave FDA approved?
No, and StemWave says so itself. Its own science page describes the device as registered with the FDA as a Class I therapeutic massager, intended for the temporary relief of minor muscle and joint aches and pains — and states plainly that FDA registration is not an FDA endorsement, approval, or clearance.
Registration means the manufacturer has notified the FDA that the device exists. It is not a review of whether it works. We break the three tiers down in detail on is shockwave therapy FDA approved?
Is SoftWave FDA approved?
SoftWave holds FDA 510(k) clearances, which is a genuine step above registration — but clearance is not approval. A 510(k) says a device is substantially similar to one already on the market; it does not require a clinical trial.
Per SoftWave’s own published list, those clearances cover chronic full-thickness diabetic foot ulcers up to 16 cm², superficial partial-thickness second-degree burns, and activation of connective tissue. Musculoskeletal pain is not among the listed indications.
So are you saying SoftWave and StemWave do not work?
No. We are not saying that, and we would not.
Plenty of people report real relief from both, activation of connective tissue is a broad clearance, and acoustic therapy in general has a solid mechanism behind it. What we are saying is narrower and more useful to you: the amount of evidence the FDA has actually examined is different for each of these devices, and the price difference is not the only difference. Know which one you are buying. If the “stem cell activation” language is what drew you in, we examine that claim here.
I already paid for a package somewhere else. Should I stop?
Not necessarily, and we have no interest in telling you that your money was wasted. Finish the course or do not — either way, come and get an honest read on whether the tissue is actually responding.
If it is, we will tell you to stay where you are. That happens, and it costs us nothing to say so.
A course somewhere else did not help me. Does that mean shockwave failed?
Not on its own. It may mean the energy never reached the tissue that was hurting.
If your problem sits several centimetres down and the device used spreads its energy across the first centimetre or two, the treatment was never going to touch it. Bring what you know — how many sessions, which device, what settings — and we will tell you whether it is worth trying properly or whether shockwave is the wrong tool for your problem entirely.
Your Next Step
Get A Straight Answer Before You Decide
Before you commit to another injection, find out whether your problem is one shockwave actually solves — and what it would cost. Asking costs you nothing.
Ask What Shockwave Costs
— And Whether You're A Candidate
One short form. A real conversation with our team.
On that call you'll get
✓ A straight answer on whether shockwave is likely to help your specific problem
✓ What a typical course involves — how many sessions, how far apart
✓ Exactly what it costs
✓ Whether something else would serve you better — including a referral elsewhere if that's the honest answer
✓ A time that works, if you decide to come in
No insurance required. No obligation. We'll come back to you within one business day.
Prefer to just ask? Call and we’ll answer the same questions on the spot.
Before you book anywhere, read page 7
Most clinics that offer shockwave own one machine — usually the radial one. Radial energy spreads out near the surface, so if your problem sits deeper than that, it does not reach it.
Page 7 of our free guide explains the difference, roughly where your own problem sits, and what to ask before you book anywhere. Fourteen pages. No cost.
Send me the free guide →Device information on this page is taken from each manufacturer’s own published materials and from the FDA’s public device databases, as of September 2026. Regulatory status can change — check the current listing before relying on it. SoftWave and StemWave are trademarks of their respective owners and are named here for identification and comparison only. Nothing here is a substitute for a conversation with your own physician or surgeon.