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FDA 510(k)

空氣壓縮腿部按摩器

K 號:K240981 · 2024-08-02

決定日期2024-08-02
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Air compression leg massager is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Xinyi Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K240981. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Air compression leg massager?

Air compression leg massager is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Huizhou Xinyi Technology Co., Ltd.. The 510(k) number is K240981.

When did Air compression leg massager receive FDA 510(k) clearance?

Air compression leg massager received FDA 510(k) clearance on 2024-08-02, under 510(k) number K240981.

Who is the listed applicant for Air compression leg massager?

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

What is the FDA product code for Air compression leg massager?

The FDA product code for Air compression leg massager is IRP.

相關臨床試驗

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其他以 Huizhou Xinyi Technology Co., Ltd. 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。

相關器械(代碼:IRP)

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。

官方來源

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