FDA 510(k)

自粘電極

K 號：K222252 · 2023-01-19

申請人Shenzhen Roundwhale Technology Co. , Ltd.

決定日期2023-01-19

產品代碼GXY

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

Self-adhesive Electrode 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 2023-01-19 under 510(k) number K222252. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Self-adhesive Electrode?

Self-adhesive Electrode is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K222252.

When did Self-adhesive Electrode receive FDA 510(k) clearance?

Self-adhesive Electrode received FDA 510(k) clearance on 2023-01-19, under 510(k) number K222252.

Who is the listed applicant for Self-adhesive Electrode?

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 Self-adhesive Electrode?

The FDA product code for Self-adhesive Electrode is GXY.

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 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 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

查看所有 7 項裝置 →

相關器械（代碼：GXY）

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。

K262654Dexus假肢系統（MSL2，MSR2）Zhejiang Qiangnao Technology Co.,Ltd K260578Ambu® NeurolineTM Cup MRI/CT (型號72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (型號72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (型號72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/S K261442夏洛特ACC25表面電極陣列；夏洛特ACC25可重用表面電極陣列Cadwell Industries, Inc.K261522生物波生物包Biowave Corporation K253237Elde醫療電極（T5/ 5公分 x 5公分電極 T10/ 5公分 x 10公分電極）Elde Medikal Sanayi ve Ticaret Anonim Sirketi K254183MR條件式杯電極Technomed Europe

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。