SOFTWAVE THERAPY
A closer look at
acoustic-wave care.
SoftWave is a branded form of acoustic-wave technology. Learn how it relates to shockwave therapy, what specific devices are cleared to do and what to ask before choosing treatment.
Education about a technology, with device availability and clinical services to be confirmed. An inquiry does not determine candidacy.
THE TECHNOLOGY
SoftWave and shockwave:
how they relate.
Shockwave therapy is a wider field of device-based treatment. SoftWave is a brand within that field. FDA summaries describe the OrthoGold 100 and OW100S systems as generating acoustic waves electrohydraulically: an electrical spark in water produces pressure pulses delivered through an applicator and coupling gel.
FDA summaries describe these models as producing an unfocused acoustic field. The wave pattern alone does not establish a better clinical result.
SoftWave does not involve injecting stem cells or PRP. Devices, applicators, energy settings and protocols should not be treated as interchangeable.
Sources: [30] U.S. Food and Drug Administration, [31] U.S. Food and Drug Administration
KNOW THE CLEARED USE
Specific devices.
Specific intended uses.
The FDA records for OrthoGold 100 (K210451) and OW100S, model OW100S-US (K213120), identify these intended uses:
A temporary increase in local blood circulation.
Activation of connective tissue.
Sources: [30] U.S. Food and Drug Administration, [31] U.S. Food and Drug Administration
Clearance is not a guarantee of regeneration.
These intended uses do not establish that the treatment regrows arthritic cartilage, reverses a disease or produces clinically proven stem-cell activation. Ask which human studies support the exact outcome being proposed.
A THOUGHTFUL TREATMENT PLAN
What should happen
before and after a session?
- Start with a diagnosis. Discuss the cause of your symptoms and whether this device and proposed use fit the clinical question.
- Review the current device instructions. The clinician should check the model, treatment site, relevant health conditions, medicines and device-specific exclusions.
- Compare the whole care plan. Discuss rehabilitation, activity changes, other treatments, cost and the possibility of no procedure today.
- Agree on a review point. Ask what improvement would matter, how it will be measured and when treatment should be reassessed or stopped.
Published ESWT research varies by condition and technology. For example, NICE guidance identifies uncertainty for Achilles tendinopathy and recommends research-only use for calcific shoulder tendinopathy. That UK guidance is not a U.S. clearance or proof of a particular SoftWave protocol.
Sources: [18] NICE (United Kingdom), [19] NICE (United Kingdom), [30] U.S. Food and Drug Administration
COMFORT & SAFETY
Noninvasive still
deserves a safety review.
The manufacturer-published instructions for the older OW100-US model list potential effects such as temporary increased pain, redness or swelling, bruising, reduced sensation, nausea or tingling. They also contain exclusions and treatment-site restrictions.
That older document is not a universal safety list for every newer model. Ask the clinician to use the current instructions for the actual equipment and proposed use, and to explain the appropriate precautions and follow-up.
Sources: [43] SoftWave / MTS Medical (manufacturer)
Take the questions with you ↓Is SoftWave the same as every shockwave machine?
No. The category includes different wave-generation methods and acoustic fields. A brand comparison should identify the devices and clinical evidence rather than assume one technology is superior for every patient.
Sources: [30] U.S. Food and Drug Administration, [31] U.S. Food and Drug Administration
Does “activation of connective tissue” mean stem-cell regrowth?
No. Those are different claims. The verified intended-use language is not proof that an arthritic joint will regrow cartilage or that a patient can avoid needed surgery.
Sources: [30] U.S. Food and Drug Administration, [31] U.S. Food and Drug Administration
Is SoftWave currently available at RegenLuma?
RegenLuma is developing its clinic services. The exact device, treating clinicians, location, available procedures and pricing will be confirmed before treatment is offered. You may ask about the evaluation process and service availability now.
Understand the option.
Then decide with a clinician.
SoftWave is a third-party brand used here for identification and education. No manufacturer affiliation or endorsement is implied. Clinical review pending.