FDA 510(k)

電擊治療與電肌肉刺激器（型號：KRES100D、KRES1010、KRES1020、KRES1080）

K 號：K213788 · 2022-05-06

申請人Dongguan Bohuikang Technology Co.,Ltd

決定日期2022-05-06

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 STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Bohuikang Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K213788. 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 STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)?

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Dongguan Bohuikang Technology Co.,Ltd. The 510(k) number is K213788.

When did TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) receive FDA 510(k) clearance?

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) received FDA 510(k) clearance on 2022-05-06, under 510(k) number K213788.

Who is the listed applicant for TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)?

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

What is the FDA product code for TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)?

The FDA product code for TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) is NUH.

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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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：NUH）

官方來源