Does SoftWave Therapy Work? The Short Answer and the Long One

The short answer: SoftWave therapy works inside a narrow, documented range, and that range is smaller than most clinic websites suggest. The U.S. Food and Drug Administration cleared the SoftWave OW100S on 12 October 2022 under 510(k) number K213120, as a Class I therapeutic massager, for exactly three claims — relief of minor muscle aches and pains, temporary increase in local blood circulation, and activation of connective tissue. It holds no U.S. clearance for arthritis, tendon repair, or skin tightening. The only published human outcome study of the device, 108 plantar fasciitis patients in the Journal of Foot and Ankle Surgery in 2021, reported average pain falling from 6.7 to 2.6 on a 10-point scale after three weekly sessions, with no control group. The long answer is where the money is.

What the FDA actually cleared, and under which category

The clearance a patient buys against, when a clinic offers SoftWave for a knee or a heel, is K213120. The FDA's letter to Tissue Regeneration Technologies, LLC lists the device as Class I under 21 CFR 890.5660, regulation name "Therapeutic Massager," product code ISA. In the agency's device classification database, ISA reads: "Massager, Therapeutic, Electric."

The enclosure lists three indications and no others: relief of minor muscle aches and pains, temporary increase in local blood circulation, activation of connective tissue.

Under the heading "Clinical Information," the 510(k) summary says "Not applicable," and states that bench and performance testing support the substantial-equivalence finding. No clinical trial data was submitted or reviewed. Equivalence to the predicate OrthoGold 100 (K210451, cleared 5 May 2021) rested on acoustic measurements and engineering tests.

A second, tougher track exists. K191961 in November 2019 and K200926 in August 2020 covered chronic diabetic foot ulcers and second-degree burns; K231710, cleared 1 September 2023, restated both in Class II under 21 CFR 878.4685, code PZL. Those apply to wounds no larger than 16 cm² in diabetic patients aged 22 and over, alongside standard ulcer care. Almost nobody walking into a chiropractic office for knee pain falls under them.

All eight SoftWave and Tissue Regeneration Technologies records in the FDA 510(k) database return no clearance mentioning arthritis, tendinopathy, or skin.

The spec sheet, and the three places the numbers stop agreeing

The K213120 comparison table gives the measured output. Energy flow density, expressed as pulse-intensity integral, runs from 0.00020 to 0.04900 mJ/mm² across intensity settings 1 through 16. The device delivers 500 to 2,000 pulses per session at a repeat rate of 1 to 8 Hz. Waves are unfocused, generated by an electrohydraulic spark gap under water. Maximum penetration depth is listed at 37.4 mm at setting 16.

Three numbers published elsewhere do not match that table.

SoftWave's own pricing page states the technology "enables an area of biological activation up to 7 cm wide and 12 cm deep." The FDA summary puts maximum penetration at 37.4 mm. These may measure different things; a claimed zone of biological effect is not acoustic penetration under IEC 61846 and IEC 63045. The company has published no method reconciling 12 cm with 3.74 cm.

The company's own trial registration sits oddly beside its filing. NCT05806203, a dyspareunia study registered by SoftWave Tissue Regeneration Technologies and completed on 30 April 2024, describes a dose of "1,000 - 1,500 shocks, 2.5-3.0 Hz, 0.06-0.10 mJ/mm2 (Intensity of 6-8)." Settings 6 to 8, per the FDA table, sit far below the device's maximum of 0.049 mJ/mm². No results have been posted, and its ClinicalTrials.gov status reads "unknown."

The published plantar fasciitis study used a protocol at 0.10 to 0.17 mJ/mm², two to three times the ceiling in the U.S. filing, on an OrthoGold 100 built by MTS in Konstanz, Germany.

Energy flux density is awkward to compare across device types. The mJ/mm² scale was built for focused shockwaves measured at a defined focal volume; radial devices are specified in bar, and unfocused sources sit between the two with no settled convention. The discrepancy may be an artifact of measurement standards. It may not be. Anyone selling a treatment plan should be able to say which.

What the one published study on this device found

Fansa, Talsania, Kennedy and O'Malley reviewed charts from patients treated with the OrthoGold 100 for plantar fasciitis between January 2013 and September 2018, publishing in the Journal of Foot and Ankle Surgery in 2021. They identified 108 patients, 119 heels, mean age 51.7. Treatment was weekly for three weeks, 2,000 impulses per session. Mean follow-up was 11.5 months, range 3 to 51.

Visual analogue scale pain fell from 6.7 ± 1.7 to 2.6 ± 2.7 (p < .001). All five Foot and Ankle Outcome Score subscales improved significantly, with gains between 15.6 and 33.8 points. Eighty-eight of 108 patients (81.5%) reported satisfaction at final follow-up.

The design carries its limits openly: retrospective, single-institution, no control group, no sham arm. Plantar fasciitis improves substantially over 11 months in many patients without any intervention, and a chart review cannot separate that out.

The senior author, Dr. Martin J. O'Malley of the Hospital for Special Surgery and Associate Professor of Orthopedics at Weill Cornell Medical College, also appears in SoftWave's marketing, quoted on the manufacturer's pricing page: "ESWT, using the OrthoGold machine is one of our most commonly employed biological treatment modalities that we use and is well-tolerated by the patients and has produced markedly improved clinical outcomes compared to other modalities." Readers weighing the study should know its senior author endorses the product commercially. Co-author Dr. John G. Kennedy is Professor and Chief of the Foot and Ankle Department at NYU Langone.

The rest of the device-specific record is thinner. NCT04880070, sponsored by Cynosure, Inc., enrolled five subjects in a single-arm, unmasked study measuring gene expression 14 days after treatment; four of the four samples analysed showed altered expression. That is the posted human evidence for "activation of connective tissue."

What shockwave therapy does for pain across all devices

The category has a far better evidence base than the brand.

Avendaño-Coy and colleagues at the Toledo Physiotherapy Research Group, Castilla-La Mancha University, pooled 14 randomised trials covering 782 participants and 877 knees in the International Journal of Surgery in 2020. They found shockwave therapy reduced pain on the visual analogue scale by a mean difference of 1.7 cm (95% CI: 1.1–2.3) and improved WOMAC scores by 13.9 points (95% CI: 6.9–20.8), with knee range of motion improving 17.5°. Their conclusion: "ESWT is an effective treatment for improving pain and functionality in patients with KOA in the short term with few minor side effects."

Read the qualifier. Short term.

Liao, Chou and Shih reviewed 24 randomised trials covering 888 patients in the Journal of Orthopaedics in 2024. Protocols ranged from 0.02 to 0.44 mJ/mm², 1,000 to 4,000 impulses, delivered once to three times weekly over three to six weeks. Significant improvements against sham clustered in trials using 0.10 to 0.24 mJ/mm² with 2,000 to 4,000 impulses. Severe knee osteoarthritis did not respond.

The two reviews disagree about dose. Avendaño-Coy's group found medium energy density outperformed both low and high; Liao's group reported a dose-response relationship favouring higher energy. Both are peer-reviewed, and no head-to-head trial has reconciled them.

Either way, SoftWave's cleared maximum of 0.049 mJ/mm² sits below the band where the significant results were found. The wave-type caveat above applies in full, and it is the strongest counterargument a clinic can offer.

On safety, the picture is reassuring. Roerdink and colleagues, with Dr. Johannes Zwerver of the Department of Sport & Exercise Medicine at University Medical Center Groningen, reviewed 39 studies covering 2,493 patients and roughly 6,450 sessions in the International Journal of Surgery in 2017. Two complications occurred across the entire dataset: one case of precordial pain, one superficial skin infection after regional anaesthesia. Pain during treatment was reported by 225 patients, transient redness by 247.

SoftWave compared with the rest of the shockwave field

The gap between SoftWave and the devices with the strongest regulatory footing comes down to what each manufacturer had to prove.

| Device | FDA pathway | Diagnosis named in the clearance | Clinical trial data required | |---|---|---|---| | SoftWave OW100S (K213120, 2022) | 510(k), Class I therapeutic massager | None — "minor muscle aches and pains" | No; summary states "Not applicable" | | HealthTronics OssaTron (P990086, 2000) | Premarket approval, Class III | Chronic proximal plantar fasciitis; chronic lateral epicondylitis added 2003 | Yes | | Dornier Epos Ultra (P000048, 2002) | Premarket approval, Class III | Chronic plantar fasciitis, symptoms 6 months or more | Yes | | EMS Swiss DolorClast (P050004, 2007) | Premarket approval, Class III | Chronic proximal plantar fasciitis, patients 18 and older | Yes |

All three premarket-approval devices carry the same FDA generic name: "Generator, shock-wave, for pain relief." SoftWave's is "Massager, Therapeutic, Electric." A patient asking which shockwave device the FDA approved to treat their actual diagnosis has a short list, and SoftWave is not on it.

SoftWave versus Sofwave: two companies, two machines, one search box

The FDA's 510(k) database lists Sofwave Medical Ltd.'s product as the "SofWave System."

They share nothing else. Sofwave Medical is an Israeli company whose device was cleared as K211483 on 15 November 2021 in Class II, product code OHV, under 21 CFR 878.4590, "Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption," with the Ulthera System as its predicate. It emits focused ultrasound at 10 to 12 MHz, heats the mid-dermis to 60–70°C at a depth of 1 to 2 mm, and is indicated for improving facial lines and wrinkles, lifting the eyebrow, and lifting lax submental and neck tissue in subjects aged 22 and over.

The clinical data in that submission is specific. Eighty subjects were treated at five U.S. sites. Blinded reviewers correctly identified pre- and post-treatment photographs for 79% of subjects on eyebrow lift and 80% on submental and neck lift. Imaging measured an average maximal eyebrow lift of 0.78 mm. Asked whether they would undergo further treatments, 43 of 72 (60%) said yes, 14 (19%) said no, and 15 (21%) were unsure.

The answer to whether SoftWave therapy works for skin tightening: the shockwave device holds no aesthetic clearance of any kind. The device that does is a different machine from a different company, using a different form of energy at a different depth. A clinic advertising "SoftWave for skin tightening" is either running a Sofwave and misspelling it, or running a shockwave machine off-label.

What it costs, and what the price disagreement reveals

SoftWave's own pricing page contradicts itself. The body text says sessions "generally cost between $150 and $350"; the FAQ further down the same page says "typically between $150 and $250." Consumer trackers including Thervo report $150 to $250 per session and $900 to $2,400 for a full series.

Session counts disagree more sharply. The manufacturer states that "most conditions respond in two to six sessions." Consumer aggregators report typical plans of six to twelve. The published plantar fasciitis protocol used three, one week apart. A patient quoted twelve sessions is being quoted four times the manufacturer's low estimate.

Treatment is nearly always cash-pay. SoftWave's materials note that Medicare may deny coverage for ESWT and advise clinics to issue an Advance Beneficiary Notice. HSA and FSA funds generally qualify.

The same page tells clinicians the machine costs between $40,000 and $99,000 and that "1–2 new patients per month can offset the monthly cost of the device." That line is aimed at clinic owners, and it sits on the page a patient reads about price. The recommended session count is set by the party amortising the equipment.

For contrast, Sofwave runs $500 to $1,200 for the brow and $2,500 to $4,500 for full face and neck, usually in one session.

When the pain in question should not go into a treatment package at all

Shockwave is elective treatment for a chronic problem that has already been identified. The routing failure worth naming is a patient buying six sessions for pain that was never worked up.

SoftWave's contraindication guidance advises avoiding treatment during pregnancy, in patients with bleeding disorders or on anticoagulants because of hematoma risk, near pacemakers or other implanted electronics, and over any malignancy in the treatment area. Listed adverse effects are localised pain, swelling, bruising, redness, and transient numbness or tingling.

Escalation guidance across urgent-care settings treats a different set of findings as reasons to stop shopping and be examined the same day: a hot, swollen, exquisitely painful joint with fever; calf swelling with warmth and tenderness; sudden severe pain after a fall in anyone over 50 or with osteoporosis; new numbness, weakness, or loss of bladder or bowel control with back pain; unexplained weight loss or night pain that wakes a person from sleep; and joint pain in someone with a recent infection, an implanted joint, or active cancer. None of those are shockwave candidates. Several are emergencies.

Before signing for a package, three checks take a minute each:

1. Ask which device the clinic operates, write down the 510(k) number, and look it up in the FDA's 510(k) database. The indications printed there are what the machine was cleared for.
2. Ask what diagnosis is being treated and how it was established — imaging, examination, or the assumption that pain in a location equals a condition.
3. Ask what the plan is if six sessions produce nothing, and get the refund and re-evaluation terms in writing before the first pulse.

Frequently asked questions

Is SoftWave therapy worth it?

For chronic plantar fasciitis or knee pain that has failed conservative care, a short trial of three to six sessions at $150 to $350 each is a defensible gamble. Published evidence supports modest short-term pain relief from shockwave generally. Committing to twelve prepaid sessions before testing response is not defensible.

What is better than SoftWave?

For a named diagnosis, devices with FDA premarket approval have a stronger regulatory footing: the OssaTron for chronic plantar fasciitis and tennis elbow, the Dornier Epos Ultra and EMS Swiss DolorClast for chronic plantar fasciitis. Each required clinical trial data. SoftWave's pain clearance required none.

What is the downside of Sofwave?

Sofwave's FDA submission recorded that only 60% of 72 subjects said they would undergo further treatment, 19% said no, and 21% were unsure. Measured eyebrow lift averaged 0.78 mm. Side effects include tingling, numbness, bruising, and redness. Full face and neck typically costs $2,500 to $4,500.

How much does SoftWave treatment cost?

SoftWave sessions run $150 to $350, with the manufacturer's own FAQ quoting $150 to $250. A full series costs $900 to $2,400. The manufacturer says most conditions respond in two to six sessions; consumer trackers report plans of six to twelve. Treatment is cash-pay and Medicare may deny coverage.

Does SoftWave therapy work for skin tightening?

No. The SoftWave shockwave device holds no FDA clearance for any aesthetic or dermatological use. The similarly named Sofwave System, made by Sofwave Medical Ltd., is a separate focused-ultrasound device cleared for facial lines, wrinkles, and lifting the eyebrow and neck. The two are unrelated products.

Does SoftWave therapy work for arthritis?

SoftWave carries no FDA clearance for arthritis. Its cleared indication covers minor muscle aches, not joint disease. Shockwave therapy as a category shows short-term knee osteoarthritis benefit — 13.9 WOMAC points in a 2020 pooled analysis — but the 2024 review found no effect in severe osteoarthritis.

How can a patient check which SoftWave device and diagnosis a clinic is using?

Ask for the 510(k) number and check it in the FDA database at accessdata.fda.gov. K213120 covers minor aches and circulation. K231710 covers diabetic foot ulcers and burns. Then ask which diagnosis is being treated and how it was confirmed. Both answers should be in writing.