FDA clearance — what it means, exactly.
What "FDA cleared" means
SoftWave TRT has gone through the FDA's 510(k) premarket notification pathway, which clears a device by showing it's substantially equivalent to legally marketed predicate devices. This is different from "FDA approved," a term used for drugs and certain higher-risk devices that go through a separate process. Using "approved" for a cleared device is inaccurate, and we avoid it on this site.
SoftWave TRT's specific clearances
SoftWave TRT holds FDA 510(k) clearance for activation of connective tissue, temporary increase in local blood circulation, and temporary relief of minor muscle and joint pain, stiffness, and muscle spasm — the clearance basis most relevant to musculoskeletal practices. Separate 510(k) clearances cover diabetic foot ulcers and superficial, partial-thickness second-degree burns, which are typically relevant to wound-care settings rather than the practices Wave The Pain Away primarily works with.
You can search the FDA's own 510(k) database directly: FDA 510(k) Premarket Notification Database.
What the independent literature says about this category.
The research below covers extracorporeal shockwave therapy (ESWT) as a category — the broader field SoftWave TRT's electrohydraulic technology belongs to. We're citing independent, peer-reviewed sources rather than manufacturer-produced statistics we can't independently verify.
Mechanism: how electrohydraulic shockwave is generated
A 2012 review in the World Journal of Orthopedics describes the three established ways orthopedic shockwave devices generate energy — electrohydraulic, electromagnetic, and piezoelectric — and explains that electrohydraulic generation uses a high-voltage spark discharge to create an acoustic pressure wave, historically the original technology adapted from kidney-stone lithotripsy for musculoskeletal use.
Read on PubMed Central →Evidence across musculoskeletal conditions
A systematic review and meta-analysis (PMC, 2020) evaluating shockwave therapy's effect on musculoskeletal conditions found good supporting evidence for conditions including calcific tendinopathy of the shoulder, Achilles tendinopathy, knee osteoarthritis, early-stage osteonecrosis of the femoral head, and plantar fasciitis — while noting evidence is more variable for conditions like lateral epicondylitis.
Read on PubMed Central →For the broader, continually updated literature on extracorporeal shockwave therapy, search PubMed directly.
SoftWave TRT's own technical & regulatory materials.
Manufacturer-published information is useful for technical specifications but isn't independent research — we label it accordingly rather than presenting it as peer-reviewed evidence.
Device specifications, indication details, and additional technical resources are published directly by the manufacturer at their official site. Wave The Pain Away is an independent practice-access program, not the device manufacturer — see our Legal & Disclaimers for that distinction.
No invented statistics. No blurred categories.
No fabricated claims
We don't publish success-rate percentages, study counts, or outcome statistics we can't trace to a verifiable, citable source.
No outcome guarantees
SoftWave TRT doesn't cure conditions and doesn't guarantee any individual outcome. Appropriateness for any patient is a clinical decision made by the treating provider.
No expanded indications
We describe SoftWave TRT's actual FDA-cleared indications only — not off-label uses framed as cleared, and not manufacturer marketing language framed as regulatory fact.