加熱電擊療/電動肌肉刺激器，FT-810R
K 號：K223308 · 2023-05-13
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器材摘要
HEATING TENS/EMS, FT-810R is the device name listed in this FDA 510(k) record. The listed applicant is Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2023-05-13 under 510(k) number K223308. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the HEATING TENS/EMS, FT-810R?
HEATING TENS/EMS, FT-810R is a medical device that received FDA 510(k) clearance on 2023-05-13. The listed applicant is Hivox Biotek, Inc.. The 510(k) number is K223308.
When did HEATING TENS/EMS, FT-810R receive FDA 510(k) clearance?
HEATING TENS/EMS, FT-810R received FDA 510(k) clearance on 2023-05-13, under 510(k) number K223308.
Who is the listed applicant for HEATING TENS/EMS, FT-810R?
The FDA 510(k) record lists Hivox Biotek, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HEATING TENS/EMS, FT-810R?
The FDA product code for HEATING TENS/EMS, FT-810R is NUH.
相關臨床試驗
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其他以 Hivox Biotek, Inc. 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。
相關器械（代碼：NUH）
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。
K261131電動肌肉刺激器（AST-105DJ、AST-105EJ、AST-105BJ、AST-105GJ、AST-303J、AST-309J、AST-310J；AST-300Q、AST-300Q-A、AST-500B；AST-500G、AST-500F；AST-500N；AST-500C、AST-500K、AST-500A；AST-300E、AST-500M、AST-500U、AST-500D；AST-500E。）Shenzhen Osto Medical Technology Co.,LtdK260412TENS 7000 可充電 4 頻道 (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS 裝置（FT-247 系列產品）（FT-247，FT-237）Hivox Biotek, Inc.K253896TENS/EMS 裝置（GUSE01）Globalcare Medical Technology Co., Ltd.K253305電擊療與電肌肉刺激器（TENS 和 Muscle Stimulator）(JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited
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。
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