SoftWave Therapy – Millennium Health & Wellness

SoftWave Therapy

SoftWave therapy utilizes acoustic waves to treat various musculoskeletal conditions and is marketed as an advanced form of shockwave therapy.

Shockwave therapy, including SoftWave therapy, has been cleared by the U.S. Food and Drug Administration (FDA) for certain medical applications. The FDA clearance typically indicates that the device has demonstrated safety and efficacy for specific indications through clinical trials or other forms of evidence.

Here are some key points about SoftWave shockwave therapy and its FDA clearance:

Treatment Principle

SoftWave therapy involves the use of acoustic waves to deliver mechanical energy to targeted tissues in the body. These acoustic waves are generated externally and focused on the area requiring treatment. The mechanical energy from the waves can stimulate tissue regeneration, improve blood flow, and reduce pain.


SoftWave therapy, like other forms of shockwave therapy, can be used to treat various musculoskeletal conditions such as tendinopathies (e.g., tennis elbow, Achilles tendinitis), plantar fasciitis, calcific tendinitis of the shoulder, and certain bone fractures. It may also be used for erectile dysfunction and other urological conditions.

FDA Clearance

SoftWave therapy devices have received FDA clearance for specific medical indications. The clearance indicates that the devices have met the FDA’s standards for safety and effectiveness for those indications. The specific indications for which SoftWave therapy is cleared may vary depending on the manufacturer and the model of the device.

Clinical Evidence

The effectiveness of SoftWave therapy, as with other forms of shockwave therapy, is supported by clinical studies and evidence. Clinical trials and research studies have evaluated its efficacy in various conditions, although the strength of evidence may vary depending on the specific condition being treated.

Professional Administration

SoftWave therapy should be administered by qualified healthcare professionals who are trained in the use of the technology and familiar with the specific protocols for different conditions.

It’s important for patients to consult with their healthcare providers to determine whether SoftWave therapy or any form of shockwave therapy is suitable for their condition and to discuss the potential risks and benefits. Additionally, patients should ensure that any device used for therapy has received FDA clearance for the intended use.