FDA 510(k)

3合一經皮神經電刺激儀（TC1241, TC2241, TS1241）

K 號：K251187 · 2025-07-28

申請人Changsha Anxiang Medical Technology Co., Ltd.

決定日期2025-07-28

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

3 in 1 TENS UNIT (TC1241, TC2241, TS1241) is the device name listed in this FDA 510(k) record. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-28 under 510(k) number K251187. 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 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)?

3 in 1 TENS UNIT (TC1241, TC2241, TS1241) is a medical device that received FDA 510(k) clearance on 2025-07-28. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K251187.

When did 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) receive FDA 510(k) clearance?

3 in 1 TENS UNIT (TC1241, TC2241, TS1241) received FDA 510(k) clearance on 2025-07-28, under 510(k) number K251187.

Who is the listed applicant for 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)?

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

What is the FDA product code for 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)?

The FDA product code for 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) is NUH.

其他以 Changsha Anxiang Medical Technology Co., Ltd. 為申請人之記錄

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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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