FDA 510(k)

R-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

K 號：K181688 · 2018-09-07

申請人Shenzhen Roundwhale Technology Co. , Ltd.

決定日期2018-09-07

產品代碼IPF

諮詢委員會PM

決定相當於

器材摘要

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; 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 2018-09-07 under 510(k) number K181688. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator?

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K181688.

When did R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator receive FDA 510(k) clearance?

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181688.

Who is the listed applicant for R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; 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 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator?

The FDA product code for R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator is IPF.

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 K180956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

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相關器械（代碼：IPF）

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。

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官方來源

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