Clinics in Denver, Colorado

FDA 510(k) clearances exist for named extracorporeal shockwave devices used in chronic plantar fasciitis and lateral epicondylitis. Kidney stone shockwave lithotripsy falls under 21 CFR 876. Low-intensity extracorporeal shockwave therapy for erectile dysfunction and other sexual health indications has not been FDA-approved in the United States as of 2026. Devices used for knee osteoarthritis, Peyronie's disease, cellulite, or non-orthopedic indications are being used off-label. Clinicians may use cleared devices off-label in the practice of medicine, but advertising must avoid suggesting that FDA clearance covers those uses.

• Colorado Medical Practice Act (C.R.S. Title 12, Article 240)
  Regulates physician scope, delegation, and the practice of medicine.
• Colorado Chiropractic Practice Act (C.R.S. Title 12, Article 215)
  Defines scope for Colorado chiropractors, which includes approved physiotherapeutic modalities.
• Colorado Consumer Protection Act (C.R.S. 6-1-101 et seq.)
  Used against deceptive health claims including misrepresentation of FDA status.

The Colorado Medical Board and the Colorado Department of Regulatory Agencies (DORA) have acted on clinics making unsupported shockwave claims, especially for ED and musculoskeletal regeneration. The Colorado Attorney General has used the Consumer Protection Act against deceptive medical advertising. Clinics that promote "FDA-approved shockwave for ED" are at elevated enforcement risk. DORA's Division of Professions and Occupations publishes disciplinary actions that can surface unlawful practice or supervision lapses for clinics operating shockwave programs without qualified personnel.