FDA 510(k)

TENS/EMS 裝置（GUSE01）

K 號：K253896 · 2026-03-04

申請人Globalcare Medical Technology Co., Ltd.

決定日期2026-03-04

產品代碼NUH

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

TENS/EMS device (GUSE01) is the device name listed in this FDA 510(k) record. The listed applicant is Globalcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-04 under 510(k) number K253896. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TENS/EMS device (GUSE01)?

TENS/EMS device (GUSE01) is a medical device that received FDA 510(k) clearance on 2026-03-04. The listed applicant is Globalcare Medical Technology Co., Ltd.. The 510(k) number is K253896.

When did TENS/EMS device (GUSE01) receive FDA 510(k) clearance?

TENS/EMS device (GUSE01) received FDA 510(k) clearance on 2026-03-04, under 510(k) number K253896.

Who is the listed applicant for TENS/EMS device (GUSE01)?

The FDA 510(k) record lists Globalcare Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS/EMS device (GUSE01)?

The FDA product code for TENS/EMS device (GUSE01) is NUH.

其他以 Globalcare Medical Technology 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。

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相關器械（代碼：NUH）

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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