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FDA 510(k)

空气压缩腿部按摩器(型号:LY-670D)

K 號:K222949 · 2022-12-22

決定日期2022-12-22
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Air Compression Leg Massager (Model: LY-670D) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Luyao Electronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-22 under 510(k) number K222949. 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 (Model: LY-670D)?

Air Compression Leg Massager (Model: LY-670D) is a medical device that received FDA 510(k) clearance on 2022-12-22. The listed applicant is Zhejiang Luyao Electronics Technology Co., Ltd.. The 510(k) number is K222949.

When did Air Compression Leg Massager (Model: LY-670D) receive FDA 510(k) clearance?

Air Compression Leg Massager (Model: LY-670D) received FDA 510(k) clearance on 2022-12-22, under 510(k) number K222949.

Who is the listed applicant for Air Compression Leg Massager (Model: LY-670D)?

The FDA 510(k) record lists Zhejiang Luyao Electronics 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 (Model: LY-670D)?

The FDA product code for Air Compression Leg Massager (Model: LY-670D) is IRP.

相關臨床試驗

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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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