FDA 510(k)

泰斯OTC電子肌肉刺激系統，型號EM35

K 號：K172241 · 2017-11-20

決定日期2017-11-20

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Tyece OTC EMS System, Model EM35 is the device name listed in this FDA 510(k) record. The listed applicant is Tyece , Ltd.. It received FDA 510(k) clearance on 2017-11-20 under 510(k) number K172241. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tyece OTC EMS System, Model EM35?

Tyece OTC EMS System, Model EM35 is a medical device that received FDA 510(k) clearance on 2017-11-20. The listed applicant is Tyece , Ltd.. The 510(k) number is K172241.

When did Tyece OTC EMS System, Model EM35 receive FDA 510(k) clearance?

Tyece OTC EMS System, Model EM35 received FDA 510(k) clearance on 2017-11-20, under 510(k) number K172241.

Who is the listed applicant for Tyece OTC EMS System, Model EM35?

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

What is the FDA product code for Tyece OTC EMS System, Model EM35?

The FDA product code for Tyece OTC EMS System, Model EM35 is NGX.

其他以 Tyece , 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。

K183454TyeceOTCEMS系統

相關器械（代碼：NGX）

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。

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官方來源

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