FDA 510(k)

腿部按摩器 RF-ALM070

K 號：K222924 · 2022-12-23

申請人Shenzhen Ruiyi Business Technology Co., Ltd.

決定日期2022-12-23

產品代碼IRP

諮詢委員會PM

決定相當於

器材摘要

Leg Massager RF-ALM070 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 2022-12-23 under 510(k) number K222924. 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 RF-ALM070?

Leg Massager RF-ALM070 is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Shenzhen Ruiyi Business Technology Co., Ltd.. The 510(k) number is K222924.

When did Leg Massager RF-ALM070 receive FDA 510(k) clearance?

Leg Massager RF-ALM070 received FDA 510(k) clearance on 2022-12-23, under 510(k) number K222924.

Who is the listed applicant for Leg Massager RF-ALM070?

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 RF-ALM070?

The FDA product code for Leg Massager RF-ALM070 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。

K232965按摩器（型號：RP-ALM070H、RP-ALM071H）

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。

K260944瑪娜冷壓系統Manamed, LLC K260529空壓按摩器（HY-1165）Xiamen High Top Electronic Technology Co., Ltd.K260948空壓按摩器（EP30B001 I）Wavepulse (Xiamen) Healthcare Technology Co., Ltd.K253919冷熱療法系統Xiamen Weiyou Intelligent Technology Co., Ltd.K252396冷凍運動2.0（AVA 501）Avanutri Equipamentos DE Saúde K254200空气压缩腿部按摩器（LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14）Wenzhou Lingfeng Electronic Technology Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。