FDA 510(k)

TENS設備-HeadaTerm 2（型號：YF-HT2）

K 號：K230782 · 2024-02-26

決定日期2024-02-26

產品代碼PCC

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 device-HeadaTerm 2 (Model: YF-HT2) is the device name listed in this FDA 510(k) record. The listed applicant is Wat Medical Technology, Inc.. It received FDA 510(k) clearance on 2024-02-26 under 510(k) number K230782. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TENS device-HeadaTerm 2 (Model: YF-HT2)?

TENS device-HeadaTerm 2 (Model: YF-HT2) is a medical device that received FDA 510(k) clearance on 2024-02-26. The listed applicant is Wat Medical Technology, Inc.. The 510(k) number is K230782.

When did TENS device-HeadaTerm 2 (Model: YF-HT2) receive FDA 510(k) clearance?

TENS device-HeadaTerm 2 (Model: YF-HT2) received FDA 510(k) clearance on 2024-02-26, under 510(k) number K230782.

Who is the listed applicant for TENS device-HeadaTerm 2 (Model: YF-HT2)?

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

What is the FDA product code for TENS device-HeadaTerm 2 (Model: YF-HT2)?

The FDA product code for TENS device-HeadaTerm 2 (Model: YF-HT2) is PCC.

其他以 Wat Medical Technology, Inc. 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。

K220503TENS設備-EmeTerm 2，型號：YF-ZTY-E2

相關器械（代碼：PCC）

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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官方來源

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