Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
General, Plastic Surgery · 21 CFR 878.4685
Treatment of diabetic foot ulcers
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
22 firms currently registered for this product code
Mts Medical Ag
KONSTANZ Baden-Wurttemberg, DE
Gorgeous Beauty Equipment Manufacture Limited
Hong Kong, HK
Softwave Tissue Regeneraton Technologies, Llc
Alpharetta, GA, US
Hebei Lufen Tech Co., Limited
Xingtai Hebei, CN
Storz Medical America, Inc.
Kennesaw, GA, US
Hebei Mita Technology Limited
Hong Kong, HK
E.m.s. Electro Medical Systems (hangzhou) Co., Ltd.
Hangzhou Zhejiang, CN
Curative Sound Therapeutics, Inc.
Carmel, IN, US
Oman Medical Beauty Manufacture Limited
Hong Kong, HK
E.m.s. Electro Medical Systems S.a.
NYON Vaud, CH
Beijing Spiritlaser Science & Technology Co., Ltd.
Beijing, CN
Storz Medical Ag
TAEGERWILEN Thurgau, CH
Beijing Perfectlaser Technology Co.,ltd
Beijing, CN
Sanhe Jumei Technology Co.,ltd
Sanhe Hebei, CN
Hebei Mita Biotechnology Limited
Hong Kong, HK
Hebei Tuosite Technology Co.,ltd
Shijiazhuang Hebei, CN
510(k) clearances
8 clearances for this product code
- E.M.S Electro Medical Systems S.AAug 13, 2025
K243279 · DOLORCLAST Focused Shock Waves
- Curative Sound TherapeuticsJul 2, 2025
K250779 · CS-Pro MED
- Softwave/Trt, LLCJul 9, 2024
K233937 · OW100S
- Softwave/Trt, LLCSep 1, 2023
K231710 · OW100S
- Storz Medical AGFeb 21, 2021
K202112 · Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
- Tissue Regeneration Technologies, LLCAug 28, 2020
K200926 · OrthoGold 100
- Tissue Regeneration TechnologiesNov 26, 2019
K191961 · OrthoGold
- Sanuwave, Inc.Dec 28, 2017
DEN160037 · dermaPACE System