免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

空氣壓力足部按摩器

K 號：K212935 · 2022-02-19

申請人Xiamen Simo Electronic Co., Ltd.
決定日期2022-02-19
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Air Pressure Foot Massager is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Simo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2022-02-19 under 510(k) number K212935. 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 Pressure Foot Massager?

Air Pressure Foot Massager is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Xiamen Simo Electronic Co., Ltd.. The 510(k) number is K212935.

When did Air Pressure Foot Massager receive FDA 510(k) clearance?

Air Pressure Foot Massager received FDA 510(k) clearance on 2022-02-19, under 510(k) number K212935.

Who is the listed applicant for Air Pressure Foot Massager?

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

What is the FDA product code for Air Pressure Foot Massager?

The FDA product code for Air Pressure Foot Massager is IRP.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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, LLCK260529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 SaúdeK254200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。

↑