FDA 510(k)

電動刺激器 - 型號 R-C1 TENS 及 EMS 刺激器，型號 R-E1 EMS 刺激器，型號 R-T1 TENS 刺激器

K 號：K180956 · 2018-06-07

申請人Shenzhen Roundwhale Technology Co. , Ltd.

決定日期2018-06-07

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2018-06-07 under 510(k) number K180956. 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 Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator?

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K180956.

When did Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator receive FDA 510(k) clearance?

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator received FDA 510(k) clearance on 2018-06-07, under 510(k) number K180956.

Who is the listed applicant for Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator?

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

What is the FDA product code for Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator?

The FDA product code for Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator is NUH.

其他以 Shenzhen Roundwhale 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。

K231423組合電療設備（型號：R-C101C、R-C101D、R-C101F、R-C101G、F100、MINI-TENS-COMB、RC101I、TENS3500）K232995神經治療設備 - 道具：電療設備電極帶，腹部肌肉練習器緊緻，AC1001，AC1002，AC1003，AC1003，AC1004，AC1005；電療設備電極帶，身體背部，AC2001，AC2002，AC2003，AC2004；電療設備電極帶，身體關節，AC3001，AC3008，AC3009，AC3010，AC3011；電療設備膝蓋電極，AC3002，AC3004，AC3006；電療設備肘關節電極，AC3003，AC3005，AC3007；電療設備 K231440組合電療設備 K222252自粘電極 K192087組合電療設備 K181688R-C1 神經電刺激器及電肌肉刺激器；R-E1- 電肌肉刺激器；R-T1 神經電刺激器

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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.,Ltd K260412TENS 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

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