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FDA 510(k)

PlayMakar 運動肌肉刺激器，型號 PRO-500

K 號：K182581 · 2018-11-21

申請人Playmakar, Inc.
決定日期2018-11-21
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

PlayMakar Sport Muscle Stimulator, Model PRO-500 is the device name listed in this FDA 510(k) record. The listed applicant is Playmakar, Inc.. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K182581. 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 PlayMakar Sport Muscle Stimulator, Model PRO-500?

PlayMakar Sport Muscle Stimulator, Model PRO-500 is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Playmakar, Inc.. The 510(k) number is K182581.

When did PlayMakar Sport Muscle Stimulator, Model PRO-500 receive FDA 510(k) clearance?

PlayMakar Sport Muscle Stimulator, Model PRO-500 received FDA 510(k) clearance on 2018-11-21, under 510(k) number K182581.

Who is the listed applicant for PlayMakar Sport Muscle Stimulator, Model PRO-500?

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

What is the FDA product code for PlayMakar Sport Muscle Stimulator, Model PRO-500?

The FDA product code for PlayMakar Sport Muscle Stimulator, Model PRO-500 is NUH.

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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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