FDA 510(k)

電療電極

K 號：K250841 · 2025-08-13

決定日期2025-08-13

產品代碼GXY

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Baisheng Medical Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251235電外科墊 K233615電外科墊 (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1)K221815電外科筆（OBS-Db，OBS-Dr，OBS-Dc，OBS-Df，OBS-Di，OBS-De）；電外科筆（OBS-Dt，OBS-Dd，OBS-Ds，OBS-Dl，OBS-Da）K162034OBS 電外科電流產生器（型號：OBS-350A）

相關器械（代碼：GXY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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