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FDA 510(k)

電擊治療與電動肌肉刺激器（LY-ET-01、LY-ET-02、LY-ET-04）

K 號：K230443 · 2023-05-22

申請人Jiangxi Royall Smart Technology Co., Ltd.
決定日期2023-05-22
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

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Royall Smart Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-22 under 510(k) number K230443. 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 TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)?

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) is a medical device that received FDA 510(k) clearance on 2023-05-22. The listed applicant is Jiangxi Royall Smart Technology Co., Ltd.. The 510(k) number is K230443.

When did TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) receive FDA 510(k) clearance?

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) received FDA 510(k) clearance on 2023-05-22, under 510(k) number K230443.

Who is the listed applicant for TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)?

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

What is the FDA product code for TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)?

The FDA product code for TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) is NUH.

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。

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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.,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

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