Is SoftWave FDA-Cleared? OW100S Shockwave Technology Explained
Advanced Technology Backed by Science and Safety
When considering any treatment, one of the first questions people ask is: “Is it safe?”
With SoftWave Therapy, the answer is grounded in both science and regulation.
SoftWave therapy uses the FDA-cleared OW100S acoustic-wave device. Its cleared indications include relief of minor muscle aches and pains, temporary increases in local blood circulation, and activation of connective tissue. The device uses patented acoustic-wave technology designed to distribute energy across a broad treatment area.
What Does FDA-Cleared Really Mean?
The SoftWave OW100S is FDA-cleared for specific uses, including relief of minor muscle aches and pains, temporary increases in local blood circulation, and activation of connective tissue.
Shockwave therapy has also been widely studied for musculoskeletal conditions, with research reporting improvements in pain and function for a number of applications (Schmitz et al., 2015).
Focused vs. Unfocused Shockwaves
Not all shockwave technologies deliver energy the same way.
Focused shockwave systems concentrate acoustic energy within a defined area. SoftWave uses an unfocused acoustic pressure field designed to distribute energy across a broader treatment area.
This allows for:
Coverage of the primary treatment area and surrounding tissue
Treatment across multiple tissue depths
Broader acoustic-wave coverage during a session
Why Unfocused Shockwaves Matter
Pain is not always isolated to one exact point. It can involve surrounding muscles, tendons, fascia, and other soft tissue.
Unfocused shockwaves allow treatment to:
Address the primary treatment area and surrounding tissue
Deliver acoustic energy across a broader area
Follow the areas where symptoms are concentrated
Clinical guidelines emphasize that treatment parameters and energy delivery are important factors in shockwave therapy outcomes (ISMST Guidelines, 2024).
A Safer, More Comprehensive Approach
Because the energy is distributed rather than concentrated, SoftWave’s approach is:
Non-invasive
Well-tolerated
Designed to work with the body’s natural healing processes
Treatment is non-invasive and does not require injections or surgical incisions.
The Bigger Picture: Technology You Can Trust
SoftWave is part of the broader field of extracorporeal shockwave therapy, which has been studied across a range of musculoskeletal conditions. Its FDA-cleared OW100S device and patented acoustic-wave technology give patients a well-documented treatment platform to consider.
Healing, Backed by Innovation
SoftWave isn’t just another device; it’s a carefully developed system designed to:
Deliver non-invasive acoustic-wave energy
Treat painful and restricted areas without injections
Support mobility and recovery goals
And it does so in a way that respects how the body naturally works.
If you’re looking for a non-invasive treatment option backed by established shockwave technology and research, SoftWave offers a clear alternative to injections or surgery.
Learn more about how treatment works, what the research says, and what to expect on our SoftWave Therapy in Los Angeles page.
