WS™遠紅外線治療儀，型號KP-B210
K 號：K160849 · 2016-12-15
廣告
器材摘要
WS(TM) Far-Infrared Therapy Unit, Model KP-B210 is the device name listed in this FDA 510(k) record. The listed applicant is Ws Far IR Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K160849. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the WS(TM) Far-Infrared Therapy Unit, Model KP-B210?
WS(TM) Far-Infrared Therapy Unit, Model KP-B210 is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Ws Far IR Medical Technology Co., Ltd.. The 510(k) number is K160849.
When did WS(TM) Far-Infrared Therapy Unit, Model KP-B210 receive FDA 510(k) clearance?
WS(TM) Far-Infrared Therapy Unit, Model KP-B210 received FDA 510(k) clearance on 2016-12-15, under 510(k) number K160849.
Who is the listed applicant for WS(TM) Far-Infrared Therapy Unit, Model KP-B210?
The FDA 510(k) record lists Ws Far IR Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for WS(TM) Far-Infrared Therapy Unit, Model KP-B210?
The FDA product code for WS(TM) Far-Infrared Therapy Unit, Model KP-B210 is ILY.
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。
相關器械（代碼：ILY）
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。
K253965CureLight醫療二極雷射系統（CureLight F2-A15；CureLight F2-B15；CureLight F2-A30；CureLight F2-B30；CureLight F3-AB30；CureLight F3-AB60。）Wuhan PHOMED Technology Company , Ltd.K242755醫用二極雷射系統（VELAS II-30B、VELAS II-30A、GBOX-15AB、GBOX-20B、CHEESE II-10B）Gigaalaser Company , Ltd.K231997SIRONA 100治療雷射系統（OEM型號EVANLAS）Cure Point Therapeutics, Inc.K223642LED 唇部修護器，型號：ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, Inc.
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。
廣告