FDA 510(k)

ThermaCare 快速治療 TENS

K 號：K181102 · 2018-09-15

決定日期2018-09-15

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

ThermaCare Quick Therapy TENS is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 2018-09-15 under 510(k) number K181102. 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 ThermaCare Quick Therapy TENS?

ThermaCare Quick Therapy TENS is a medical device that received FDA 510(k) clearance on 2018-09-15. The listed applicant is Pfizer, Inc.. The 510(k) number is K181102.

When did ThermaCare Quick Therapy TENS receive FDA 510(k) clearance?

ThermaCare Quick Therapy TENS received FDA 510(k) clearance on 2018-09-15, under 510(k) number K181102.

Who is the listed applicant for ThermaCare Quick Therapy TENS?

The FDA 510(k) record lists Pfizer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ThermaCare Quick Therapy TENS?

The FDA product code for ThermaCare Quick Therapy TENS is NUH.

相關器械（代碼：NUH）

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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

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器材摘要

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相關器械（代碼：NUH）

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