FDA 510(k)

空氣壓縮腿部按摩器 HY-1117A

K 號：K212713 · 2022-01-18

申請人Xiamen High Top Electronic Technology Co., Ltd.

決定日期2022-01-18

產品代碼IRP

諮詢委員會PM

決定相當於

器材摘要

Air compression leg massager HY-1117A is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen High Top Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-18 under 510(k) number K212713. 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 HY-1117A?

Air compression leg massager HY-1117A is a medical device that received FDA 510(k) clearance on 2022-01-18. The listed applicant is Xiamen High Top Electronic Technology Co., Ltd.. The 510(k) number is K212713.

When did Air compression leg massager HY-1117A receive FDA 510(k) clearance?

Air compression leg massager HY-1117A received FDA 510(k) clearance on 2022-01-18, under 510(k) number K212713.

Who is the listed applicant for Air compression leg massager HY-1117A?

FDA 510(k) 記錄將厦门高頂電子技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Air compression leg massager HY-1117A?

The FDA product code for Air compression leg massager HY-1117A is IRP.

其他以 Xiamen High Top Electronic 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。

K260529空壓按摩器（HY-1165）

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

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