FDA 510(k)

Ems足部刺激器（型號：HK701、HK701A、HK701B、HK701C）

K 號：K221251 · 2022-07-29

申請人Guangzhou Huakai Electronic Technology Co., Ltd.

決定日期2022-07-29

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

Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Huakai Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K221251. 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 Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)?

Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Guangzhou Huakai Electronic Technology Co., Ltd.. The 510(k) number is K221251.

When did Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) receive FDA 510(k) clearance?

Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) received FDA 510(k) clearance on 2022-07-29, under 510(k) number K221251.

Who is the listed applicant for Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)?

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

What is the FDA product code for Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)?

The FDA product code for Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) is NUH.

相關器械（代碼：NUH）

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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）

官方來源