FDA 510(k)

迷你電擊療法設備

K 號：K182871 · 2019-08-01

申請人Shenzhen Jumper Medical Equipment Co., Ltd.

決定日期2019-08-01

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

Mini TENS Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jumper Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-08-01 under 510(k) number K182871. 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 Mini TENS Therapy Device?

Mini TENS Therapy Device is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is Shenzhen Jumper Medical Equipment Co., Ltd.. The 510(k) number is K182871.

When did Mini TENS Therapy Device receive FDA 510(k) clearance?

Mini TENS Therapy Device received FDA 510(k) clearance on 2019-08-01, under 510(k) number K182871.

Who is the listed applicant for Mini TENS Therapy Device?

The FDA 510(k) record lists Shenzhen Jumper Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mini TENS Therapy Device?

The FDA product code for Mini TENS Therapy Device is NUH.

其他以 Shenzhen Jumper Medical Equipment Co., 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。

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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。

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