FDA 510(k)

V2 非處方藥疼痛緩解 TENS

K 號：K182767 · 2018-10-26

決定日期2018-10-26

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

V2 OTC Pain Relief TENS 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 2018-10-26 under 510(k) number K182767. 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 V2 OTC Pain Relief TENS?

V2 OTC Pain Relief TENS is a medical device that received FDA 510(k) clearance on 2018-10-26. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K182767.

When did V2 OTC Pain Relief TENS receive FDA 510(k) clearance?

V2 OTC Pain Relief TENS received FDA 510(k) clearance on 2018-10-26, under 510(k) number K182767.

Who is the listed applicant for V2 OTC Pain Relief TENS?

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 V2 OTC Pain Relief TENS?

The FDA product code for V2 OTC Pain Relief TENS is NUH.

其他以 Everyway Medical Instruments Co.,Ltd 為申請人之記錄

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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 K202317Li電池驅動OTC TENS/EMS，型號EV-804、型號EV-805及型號EV-806

查看所有 13 項裝置 →

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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