CS-Pro MED

The CS-Pro MED is a handheld, battery-operated device that produces high-pressure, focused acoustic shock waves for treating chronic, full-thickness diabetic foot ulcers with wound areas no larger than 16 cm². It is indicated for adults 22 years and older with diabetic foot ulcers lasting more than 30 days, and must be used in conjunction with standard diabetic ulcer care.

The CS-Pro MED uses piezoelectric transducers driven by an electrical signal to generate acoustic shock waves, with five adjustable standoff sizes (58 x 38mm) to control treatment depth. Key differences from the predicate (DuoLith SD1 with C-ACTOR) include: battery power (3.7 VDC, 2300 mAh lithium-ion) versus AC-mains power; higher pulse repeat rate (2–12 Hz versus 1–8 Hz); smaller, lighter handheld design (3.7 kg versus unknown weight); and slightly broader operating temperature range (5°–37°C versus 10°–30°C).

Electrical safety per IEC 60601-1:2005/A1:2012 + A2:2020 and IEC 60601-2-36:2014-04; electromagnetic compatibility per IEC 60601-1-2:2014/A1:2020; risk management per ISO 14971:2019; and biocompatibility per ISO 10993-1 with FDA guidance dated September 4, 2020.

The CS-Pro MED generates extracorporeally induced acoustic shock waves using piezoelectric technology that creates the same type of acoustic pressure wave as the predicate, achieving comparable acoustic parameters and the same mechanism of action. Although the CS-Pro MED differs in power supply, pulse repeat rate, size, weight, and operating temperature, these differences do not raise new safety or effectiveness questions because the device's core function—delivery of focused acoustic shock waves—remains identical to the predicate, and all differences are either improvements (handheld, rechargeable battery) or within acceptable ranges that do not affect therapeutic performance.