Electrotherapy Electrodes
FDA 510(k) K250841 · Baisheng Medical Co., Ltd.
510(k) numberK250841
Submission
- Device name
- Electrotherapy Electrodes
- Applicant
- Baisheng Medical Co., Ltd.
Guangdong, CN - Received
- March 20, 2025
- Decision date
- August 13, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Electrotherapy Electrodes cleared by the FDA?
Electrotherapy Electrodes (K250841) received a 510(k) decision of Substantially Equivalent on August 13, 2025, 146 days after the submission was received.
What is the product code of K250841?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.