FDA Product Code PZL: Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Treatment Of Diabetic Foot Ulcers
Leading manufacturers include Softwave/Trt, LLC, E.M.S Electro Medical Systems S.A and Curative Sound Therapeutics.
FDA 510(k) Cleared Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers Devices (Product Code PZL)
About Product Code PZL - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PZL since 2017, with 7 receiving FDA clearance (average review time: 212 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for PZL submissions have been consistent, averaging 206 days recently vs 215 days historically.
PZL devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →