FDA 510(k)

Li電池驅動OTC TENS/EMS，型號EV-804、型號EV-805及型號EV-806

K 號：K202317 · 2020-11-13

決定日期2020-11-13

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

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2020-11-13 under 510(k) number K202317. 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 Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806?

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 is a medical device that received FDA 510(k) clearance on 2020-11-13. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K202317.

When did Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 receive FDA 510(k) clearance?

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 received FDA 510(k) clearance on 2020-11-13, under 510(k) number K202317.

Who is the listed applicant for Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806?

The FDA 510(k) record lists Everyway Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806?

The FDA product code for Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 is NUH.

其他以 Everyway Medical Instruments 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。

K251856立式電池驅動OTC TENS/EMS組合刺激器，型號Z4 K222488Everyway 適用OTC TENS K213116Everyway 緊急失禁刺激系統 K202849Everyway 適用OTC TENS，型號N103A/N302 K202470Li電池驅動OTC TENS/EMS，型號EM-6000、EM-6100、EM-6200及EM-6300 K201335立式電池驅動OTC TENS/EMS組合刺激器

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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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