FDA 510(k)

按摩器（型號：RP-ALM070H、RP-ALM071H）

K 號：K232965 · 2024-11-20

申請人Shenzhen Ruiyi Business Technology Co., Ltd.

決定日期2024-11-20

產品代碼IRP

諮詢委員會PM

決定相當於

器材摘要

Leg Massager (Models:RP-ALM070H, RP-ALM071H) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Ruiyi Business Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K232965. 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 Leg Massager (Models:RP-ALM070H, RP-ALM071H)?

Leg Massager (Models:RP-ALM070H, RP-ALM071H) is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Shenzhen Ruiyi Business Technology Co., Ltd.. The 510(k) number is K232965.

When did Leg Massager (Models:RP-ALM070H, RP-ALM071H) receive FDA 510(k) clearance?

Leg Massager (Models:RP-ALM070H, RP-ALM071H) received FDA 510(k) clearance on 2024-11-20, under 510(k) number K232965.

Who is the listed applicant for Leg Massager (Models:RP-ALM070H, RP-ALM071H)?

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

What is the FDA product code for Leg Massager (Models:RP-ALM070H, RP-ALM071H)?

The FDA product code for Leg Massager (Models:RP-ALM070H, RP-ALM071H) is IRP.

其他以 Shenzhen Ruiyi Business 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。

K222924腿部按摩器 RF-ALM070

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。

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官方來源

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