Our Technology
SoftWave TRT
Shockwave Pain Institute uses SoftWave TRT technology, manufactured by Tissue Regeneration Technologies (TRT). Here's what that technology is, how it's regulated, and — importantly — how it's different from an unrelated company with a very similar name.
What SoftWave TRT Is
SoftWave TRT is a brand of extracorporeal shockwave device manufactured by Tissue Regeneration Technologies, LLC. It uses an electrohydraulic, broad-focused method of generating acoustic pressure waves, which the manufacturer distinguishes from some other focused or radial shockwave systems on the market. As with any manufacturer's technical claims, we encourage patients to evaluate the underlying peer-reviewed research (see below) rather than manufacturer marketing language alone — which is exactly the standard we hold ourselves to on this page.
Important: Not the same company as 'Sofwave'
SoftWave TRT / Tissue Regeneration Technologies is a completely different company and technology from Sofwave Medical, which makes an ultrasound-based device used exclusively for cosmetic skin-tightening treatments. The names are easy to confuse in a search engine, but the companies, technologies, indications, and regulatory records are entirely unrelated. Nothing on this page or elsewhere on this site refers to, or borrows evidence from, Sofwave Medical's aesthetic device.
How Treatment Is Administered
A handheld applicator is placed against the skin over the treatment area, and acoustic pressure waves are delivered in a series of pulses. No needles, incisions, or anesthesia are used. Session length and number of sessions are determined by your provider based on your evaluation and the condition being treated.
Verified FDA Regulatory Record
We believe patients deserve accurate regulatory language, not marketing shorthand. Below is the actual, verified FDA 510(k) record for the device (independently confirmed against the FDA's own database and cross-checked with the manufacturer's press materials — see the source link).
FDA 510(k) Record
- Device:
- OrthoGold 100
- Applicant:
- Tissue Regeneration Technologies, LLC — Woodstock, GA
- 510(k) number:
- K210451
- Decision date:
- May 5, 2021
- Device class:
- Class I
- Regulation:
- 21 CFR 890.5660
- Cleared indications for use:
- Relief of minor muscle aches and pains; temporary increase in local blood circulation; activation of connective tissue.
What 'cleared' means — and what this record does not say
A 510(k) clearance means the FDA determined the device is "substantially equivalent" to a legally marketed predicate device — it is a different regulatory pathway than FDA "approval," and we use the word "cleared" deliberately throughout this site rather than "approved." Just as importantly: this clearance covers general indications (minor aches and pains, blood circulation, connective tissue activation) — it is not an FDA-cleared indication specifically for plantar fasciitis, tendinopathy, or any other diagnosis named on this website. The condition-specific claims on our condition pages are supported by the independent clinical research cited there (see Research Center), not by this regulatory record.
Why We Use This Technology
After personally undergoing multiple surgeries, Dr. LeVee developed a strong interest in treatments that may help patients address pain and impaired function before pursuing more invasive options. He chose SoftWave TRT because it offers a non-invasive, drug-free approach that can support the body’s natural healing processes and be incorporated into an individualized treatment plan when clinically appropriate.
The clinic uses the OrthoGold 100 from SoftWave Tissue Regeneration Technologies. No other shockwave device is used.
Provider relationship disclosure
Dr. Mark LeVee, DC, is a Regional Instructor and Distributor Partner with SoftWave Tissue Regeneration Technologies. That relationship may create a financial or professional interest in the technology. We disclose it so patients can weigh the information appropriately, and we separate manufacturer specifications from independent clinical evidence throughout this site.
Potential Studied Uses
SoftWave TRT and broader extracorporeal shockwave technology have been studied for a range of musculoskeletal applications. Our Research Center distinguishes clearly between research conducted specifically with SoftWave/TRT devices and the broader extracorporeal shockwave evidence base, since these should not be treated as interchangeable.
Safety
See our Shockwave Therapy page for general safety information and contraindications, which apply to SoftWave TRT as a shockwave-based modality.
New Patient Exam + First Treatment — $99
First treatment provided when clinically appropriate following your examination.