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Data / Medical devices / Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers (PZL): 14 FDA-registered makers in 5 countries

14 establishments in 5 countries are registered with the FDA to make Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers (product code PZL, Class 2, 21 CFR 878.4685). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on August 13, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Product code
PZL
Device class
2
Regulation
878.4685
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
China5
Hong Kong4
United States2
Switzerland2
Germany1

Makers of Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Softwave Tissue Regeneraton Technologies, LLCAlpharetta, GA, United StatesComplaint file establishment, Specification developer4July 9, 2024000api.fda.gov
MTS Medical AGKONSTANZ Baden-Wurttemberg, GermanyManufacturer2July 9, 2024000api.fda.gov
Curative Sound Therapeutics, Inc.Carmel, IN, United StatesManufacturer1July 2, 2025000api.fda.gov
E.M.S. Electro Medical Systems S.A.NYON Vaud, SwitzerlandComplaint file establishment, Specification developer1August 13, 2025000api.fda.gov
Storz Medical AGTAEGERWILEN Thurgau, SwitzerlandManufacturer1February 21, 2021000api.fda.gov
Beijing Perfectlaser Technology Co.,ltdBeijing, ChinaExporter to the US, Manufacturer0000api.fda.gov
E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Gorgeous Beauty Equipment Manufacture LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Hebei Lufen Tech Co., LimitedXingtai Hebei, ChinaManufacturer0000api.fda.gov
Hebei Mita Biotechnology LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Hebei Mita Technology LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Hebei Tuosite Technology Co.,ltdShijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Oman Medical Beauty Manufacture LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Sanhe Jumei Technology Co.,ltdSanhe Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov

Updated August 13, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.