Decision Date2025-08-13
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Electrotherapy Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Baisheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K250841. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Electrotherapy Electrodes?
Electrotherapy Electrodes is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Baisheng Medical Co., Ltd.. The 510(k) number is K250841.
When did Electrotherapy Electrodes receive FDA 510(k) clearance?
Electrotherapy Electrodes received FDA 510(k) clearance on 2025-08-13, under 510(k) number K250841.
Who is the listed applicant for Electrotherapy Electrodes?
The FDA 510(k) record lists Baisheng Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Electrotherapy Electrodes?
The FDA product code for Electrotherapy Electrodes is GXY.
Other records listing Baisheng Medical Co., Ltd. as applicant
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.