FDA 510(k)

無線TENS/EMS，Bruno，Aela

K 號：K220997 · 2022-09-01

決定日期2022-09-01

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

Wireless TENS/EMS, Bruno, Aela is the device name listed in this FDA 510(k) record. The listed applicant is Zmi Elecronics , Ltd.. It received FDA 510(k) clearance on 2022-09-01 under 510(k) number K220997. 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 Wireless TENS/EMS, Bruno, Aela?

Wireless TENS/EMS, Bruno, Aela is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is Zmi Elecronics , Ltd.. The 510(k) number is K220997.

When did Wireless TENS/EMS, Bruno, Aela receive FDA 510(k) clearance?

Wireless TENS/EMS, Bruno, Aela received FDA 510(k) clearance on 2022-09-01, under 510(k) number K220997.

Who is the listed applicant for Wireless TENS/EMS, Bruno, Aela?

The FDA 510(k) record lists Zmi Elecronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless TENS/EMS, Bruno, Aela?

The FDA product code for Wireless TENS/EMS, Bruno, Aela is NUH.

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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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：NUH）

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