FDA 510(k)

TENS設備-EmeTerm 2，型號：YF-ZTY-E2

K 號：K220503 · 2022-04-23

決定日期2022-04-23

產品代碼GZJ

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-EmeTerm 2, Model: YF-ZTY-E2 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 2022-04-23 under 510(k) number K220503. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TENS device-EmeTerm 2, Model: YF-ZTY-E2?

TENS device-EmeTerm 2, Model: YF-ZTY-E2 is a medical device that received FDA 510(k) clearance on 2022-04-23. The listed applicant is Wat Medical Technology, Inc.. The 510(k) number is K220503.

When did TENS device-EmeTerm 2, Model: YF-ZTY-E2 receive FDA 510(k) clearance?

TENS device-EmeTerm 2, Model: YF-ZTY-E2 received FDA 510(k) clearance on 2022-04-23, under 510(k) number K220503.

Who is the listed applicant for TENS device-EmeTerm 2, Model: YF-ZTY-E2?

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-EmeTerm 2, Model: YF-ZTY-E2?

The FDA product code for TENS device-EmeTerm 2, Model: YF-ZTY-E2 is GZJ.

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。

K230782TENS設備-HeadaTerm 2（型號：YF-HT2）

相關器械（代碼：GZJ）

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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