FDA 510(k)

壓力治療系統

K 號：K161907 · 2017-02-23

決定日期2017-02-23

產品代碼IRP

諮詢委員會PM

決定相當於

器材摘要

Pressure Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Senyang Co., Ltd.. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K161907. 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 Pressure Therapy System?

Pressure Therapy System is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Xiamen Senyang Co., Ltd.. The 510(k) number is K161907.

When did Pressure Therapy System receive FDA 510(k) clearance?

Pressure Therapy System received FDA 510(k) clearance on 2017-02-23, under 510(k) number K161907.

Who is the listed applicant for Pressure Therapy System?

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

What is the FDA product code for Pressure Therapy System?

The FDA product code for Pressure Therapy System is IRP.

其他以 Xiamen Senyang 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。

K192358壓力治療系統 PT1003 K181409壓力治療系統 PT1003

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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