FDA 510(k)

Balego TENS數位版及配件，用於緩解疼痛（OTC）

K 號：K181207 · 2018-06-06

申請人Everyway Medical Instruments Co., Ldt.

決定日期2018-06-06

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

Balego TENS Digital Edition with Accessories for Pain Relief (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co., Ldt.. It received FDA 510(k) clearance on 2018-06-06 under 510(k) number K181207. 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 Balego TENS Digital Edition with Accessories for Pain Relief (OTC)?

Balego TENS Digital Edition with Accessories for Pain Relief (OTC) is a medical device that received FDA 510(k) clearance on 2018-06-06. The listed applicant is Everyway Medical Instruments Co., Ldt.. The 510(k) number is K181207.

When did Balego TENS Digital Edition with Accessories for Pain Relief (OTC) receive FDA 510(k) clearance?

Balego TENS Digital Edition with Accessories for Pain Relief (OTC) received FDA 510(k) clearance on 2018-06-06, under 510(k) number K181207.

Who is the listed applicant for Balego TENS Digital Edition with Accessories for Pain Relief (OTC)?

The FDA 510(k) record lists Everyway Medical Instruments Co., Ldt. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Balego TENS Digital Edition with Accessories for Pain Relief (OTC)?

The FDA product code for Balego TENS Digital Edition with Accessories for Pain Relief (OTC) is NUH.

其他以 Everyway Medical Instruments Co., Ldt. 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。

K181849iStim S2 非處方藥疼痛緩解 TENS

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。

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