November 19, 2025

As the manufacturer, I design our shockwave therapy systems 1 to include a versatile range of applicator heads so clinicians can adjust treatment depth, focus, and comfort across different conditions. Most professional shockwave therapy machines include four interchangeable applicator heads, typically ranging from 6 mm to 25 mm in diameter—a configuration similar to many clinical […]

As the manufacturer, I am asked this in nearly every EU tender: “Is Class IIb or III mandatory for shockwave systems?” The real answer depends on intended purpose, energy delivery, and MDR Annex VIII rules 1—not on a single, blanket class. MDR Class IIb or III is not automatically mandatory for all shockwave therapy devices.