RegWardenFDA facility compliance records
Facility

E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2024: 1 recalls20172018201920202021202220231202420252026
  • Recalls (1)

Devices registered here (1)

  • Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
    Product code PZL (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4685

Recalls & enforcement

  • Class IIOngoing2024-03-13
    Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd. (FEI 3008530360) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008530360-e-m-s-electro-medical-systems-hangzhou-c/

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